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Senior Manager, Clinical Product Quality - Post Market Quality & Complaints-logo
Senior Manager, Clinical Product Quality - Post Market Quality & Complaints
Edwards Lifesciences CorpNorth Carolina, NC
This position offers the flexibility of being fully remote, but the selected candidate must be residing within the United States. Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Clinical Product Quality will plan and lead initiatives around Post-Market Quality Assurance, specifically Complaint Handling, assuring appropriate investigation and documentation of product complaints, including reporting of events to regulatory Agencies. Provide Medical/Clinical Guidance to Complaint Staff and Engineers to understand the nature of complaints and possible health risks. How you will make an impact: Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, and required regulatory reporting (MDR, MDV, etc.). Review and approve global reporting decisions, MDRS/MIRs prior to submission, and complaints for closure. Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution. May provide training to complaint staff on patient anatomy and medical conditions, products and procedure, and internal policies and procedures. Develop and plan Medical/Clinical Guidance projects and activities with accountability for successful completion of all project deliverables. Educates complaint staff to understand nature of complaints and possible health risks; Interprets complaint data for Quality compliance staff, complaint investigators and other Quality department personnel. Authors clinically based product specific scripts to guide complaint handlers in appropriate investigation. Provide Clinical input for quality escalations, risk assessments, nonconformances and CAPAs. Provide direction and guidance to project teams to execute tactical clinical product quality projects and/or initiatives. Identify and evaluate clinical product quality process improvement and/or course correction/course alignment opportunities, including owning nonconformances and CAPAs. Documents and maintains complaint coding and reportability decisions to Global Regulatory Authorities. Coding and reporting decisions are documented and maintained in the Complaint Coding and Reportability Matrix and utilized as guidance by the Post-Market QA Team for complaints investigations. In aggregate, analyzes and interprets complaint data and prepares responses to external requests (i.e. regulatory agency requests) or internal requests (i.e. regulatory submission support, R&D product development or quality investigation support). Analyze and present complaint trend data at Management review, recommend areas for additional review or investigation. Performs imaging reviews with clinicians, determines root cause of the reported events, and writes a final report in order to satisfy regulatory investigational requirements. Other duties assigned by leadership What you'll need (Required Qualifications): Bachelor's degree in nursing, scientific, or quality related field plus a minimum of 10 years of relevant experience; or a Master's degree in nursing, scientific, or quality related field plus a minimum of 8 years of relevant experience. Medical device industry, quality systems, or hospital/clinical experience (e.g. cath lab, cardiac care, ICU, OR, or cardiovascular/endovascular interventions). Combination of nursing, quality and/or medical device industry experience is a strong plus. Supervisory or people leadership experience. Registered nurse with current state license in good standing What else we look for (Preferred Qualifications): Demonstrated ability to lead and manage a team. Proven experience with complaint handling and managing MDR (Medical Device Reporting). Extensive experience with CAPAs, NCRs, and Failure Analysis. Medical Device (cardiovascular, endovascular, or other critical care/surgical products) Strong understanding of risk management principles and practices. Proficiency in interpreting and analyzing clinical complaint data. Strong analytical skills with the ability to identify trends and conduct root cause analysis/investigations. Proven successful project management skills Strong working knowledge of Medical Device regulations and standards (e.g., FDA, ISO 13485, MDD). Experience utilizing Microsoft Office Suite Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For Illinois (IL), the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 4 days ago

Post Acute Mobile Integrated Health Paramedic Coordinator-logo
Post Acute Mobile Integrated Health Paramedic Coordinator
Nebraska Medical CenterOmaha, NE
Serious Medicine is what we do. Being extraordinary is who we are. Every colleague plays a key role in upholding this promise to our patients and their families. Shift: First Shift (United States of America) Post Acute Mobile Integrated Health Paramedic Coordinator Nebraska Medicine is seeking a Paramedic Coordinator to join our Emergency Services team in our new Post Acute Mobile Integrated Health Paramedicine Program. Shift Details: Exempt | Full Time | Day Shift Position Summary Knowledge of paramedicine program, which encompasses the post hospital care of patients across the care continuum. Functions as a liaison between clinicians and enterprise paramedicine staff to promote care in the community space. Accountable to support the development, maintenance, and coordination of programs, policies, education, compliance, and performance improvement related to Post Acute Paramedicine Program. Provide direct patient care as needed. Required Qualifications: Minimum of three years Emergency Medicine or Paramedicine. High school education or equivalent required. Bachelor's degree in nursing (BSN) OR Associate's degree in nursing (ADN) with 25 years of nursing experience required. Basic Life Support (BLS) certification required, must be from an American Heart Association (AHA) endorsed program required. Currently licensed as a Registered Nurse in the state of Nebraska or current compact state license required. Preferred Qualifications: Managerial or programmatic coordination experience preferred. Organize and manage multiple concurrent tasks preferred. Strong organizational, analytical and research skills preferred. Well-ordered approach to problem solving preferred. Ability to anticipate and respond effectively to changes in direction and priorities preferred. Effective interpersonal and communication skills preferred. Flexibility and dedication to team environment preferred. Knowledge of Zoll telemetry, MUSE systems, EKG system and cart, cardiac event recorders, and holter monitors preferred. Experience with Microsoft Office and hospital information system preferred Nebraska Medicine is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, marital status, sex, age, national origin, disability, genetic information, sexual orientation, gender identity and protected veterans' status.

Posted 30+ days ago

Associate Director Regulatory Affairs Post Marketing-logo
Associate Director Regulatory Affairs Post Marketing
SupernusRockville, MD
Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes. Job Summary: The Associate Director of Post-Marketing is responsible for providing management of a post-marketing regulatory activities, ensuring compliance with regulatory requirements, and supporting lifecycle management of Supernus products. Essential Duties & Responsibilities: Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this party is responsible for: Regulatory review of advertising and promotional materials for assigned products, submission of materials, and representing Regulatory Affairs on promotional review committee. Acts as primary source of contact for marketing departments for assigned products Assist in the creation of and implementation of changes to product labeling including: Package inserts and structured product label. Medication guides. Container labels. Core safety data sheets Maintaining Regulatory archive of product labeling May be asked to be a department representative on selected project teams for commercial products, for completion of post-marketing commitments May assist with interface with licensees regarding ex-US sales and promotion and labeling of commercial products May attend scientific sessions for regulatory affairs department. Other duties as assigned Supervisory Responsibilities: Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives. Understands Company Policy and procedure to be able to guide direct reports appropriately. Knowledge & Other Qualifications: Bachelor's degree required, Master's degree preferred. Relevant Ph.D. with minimum 5+ years or Master's/ Bachelor's with minimum 8+ years relevant experience in pharmaceutical regulatory affairs. Minimum of 5 years of experience (preferably recent) reviewing advertising and promotional materials required Experience with direct interface with FDA Office of Prescription Drug Promotion desirable Experience with creation and implementation of product labeling highly desirable Pharmacy/medical and or medical-legal background strongly preferred. Experience with neuroscience products desirable Experience with the Microsoft Office Suite. Other Characteristics: Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. Ability of having an innovative and dynamic approach to work. A self-starter able to work independently but comfortable working in a team environment. Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others. Capable of performing other duties as assigned by Management. Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $140,000 to $175,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Posted 30+ days ago

Philanthropy Officer - Post Acute Care Services, Day Shift, Rehab Philanthropy-logo
Philanthropy Officer - Post Acute Care Services, Day Shift, Rehab Philanthropy
Adventist HealthcareSilver Spring, MD
Adventist Rehabilitation - Rockville If you are a current Adventist HealthCare employee, please click this link to apply through your Workday account. Adventist HealthCare seeks to hire an experienced Philanthropy Officer for our Philanthropy department who will embrace our mission to extend God's care through the ministry of physical, mental, and spiritual healing. As a Philanthropy Officer, you will: Identify, cultivate, and steward relationships with individual, corporate, and foundation donors to grow support. Develop and execute donor engagement and solicitation strategies, focusing on both current and prospective donors. Develop philanthropic awareness Design and implement fundraising campaigns and events to engage the community and raise awareness. Develop personalized stewardship plans for major donors and oversee donor recognition programs. Collaborate with leadership to identify needs and opportunities, leveraging identified opportunities for funding to prepare and present proposals to prospective donors and partners. Partner with Operations Teams to build relationships and referral streams. Integrate with philanthropic colleagues to ensure donors can fulfill their philanthropic goals. Support the growth and expansion of the program through strategic fundraising initiatives. Identify new opportunities and innovative approaches to increase program reach and impact. Collaborate with program leadership to align fundraising strategies with programmatic goals.. Collaborate with clinicians to promote a culture of philanthropy, providing training and engagement opportunities to integrate philanthropy into the clinical team's work, with an emphasis on grateful patient referrals. Become a known and trusted resource to clinicians seeking to address needs and opportunities within their purviews. Develop and manage the budgets in alignment with fundraising goals. Monitor and analyze fundraising metrics to evaluate the effectiveness of strategies. Work with entity leaders and finance to deploy philanthropic funds in keeping with the donor's intentions and the business needs Develop a strategy and methodology to spend unrestricted funds. Work in close partnership with the marketing team to enhance the philanthropic visibility of the organization/program, including creating donor-focused communications and collaborating on campaigns that highlight the program's impact and funding needs. Represent the organization at community events and speaking engagements. Qualifications include: Bachelor's or Associate's with 5-10 years relevant experience Work Schedule: Day Shift #GR8 Other Pay Range: $77,313.60 - $115,980.80 If the salary range is listed as $0 or if the position is Per Diem (with a fixed rate), salary discussions will take place during the screening process. Under the Fair Labor Standards Act (FLSA), this position is classified as: United States of America (Exempt) At Adventist HealthCare our job is to care for you. We do this by offering: Work life balance through nonrotating shifts Recognition and rewards for professional expertise Free Employee parking Medical, Prescription, Dental, and Vision coverage for employees and their eligible dependents effective on your date of hire Employer-paid Short & Long-Term Disability, Basic Life Insurance and AD&D, (short-term disability buy-up available) Paid Time Off Employer retirement contribution and match after 1-year of eligible employment with a 3-year vesting period Voluntary benefits include flexible spending accounts, legal plans, and life, pet, auto, home, long term care, and critical illness & accident insurance Subsidized childcare at participating childcare centers Tuition Reimbursement Employee Assistance Program (EAP) support As a faith-based organization, with over a century of caring for the communities in the Maryland area, Adventist HealthCare has earned a reputation for high-quality, compassionate care. Adventist HealthCare was the first and is the largest healthcare provider in Montgomery County. If you want to make a difference in someone's life every day, consider a position with a team of professionals who are doing just that, making a difference. Join the Adventist HealthCare team today, apply now to be considered! COVID-19 Vaccination Adventist HealthCare strongly recommends all applicants to be fully vaccinated for COVID-19 before commencing employment. Applicants may be required to furnish proof of vaccination. Tobacco and Drug Statement Tobacco use is a well-recognized preventable cause of death in the United States and an important public health issue. In order to promote and maintain a healthy work environment, Adventist HealthCare will not hire applicants for employment who either state that they are nicotine users or who test positive for nicotine and drug use. While some jurisdictions, including Maryland, permit the use of marijuana for medical purposes, marijuana continues to be classified as an illegal drug under the federal Controlled Substances Act. As a result, medical marijuana use will not be accepted as a valid explanation for a positive drug test result. Adventist HealthCare will withdraw offers of employment to applicants who test positive for Cotinine (nicotine) and marijuana. Those testing positive are given the opportunity to re-apply in 90 days, if they can truthfully attest that they have not used any nicotine products in the past ninety (90) days and successfully pass follow-up testing. ("Nicotine products" include, but are not limited to: cigarettes, cigars, pipes, chewing tobacco, e-cigarettes, vaping products, hookah, and nicotine replacement products (e.g., nicotine gum, nicotine patches, nicotine lozenges, etc.). Equal Employment Opportunity Adventist HealthCare is an Equal Opportunity/Affirmative Action Employer. We are committed to attracting, engaging, and developing the best people to cultivate our mission-centric culture. Our goal is to have a welcoming, equitable, and safe place to work and grow for all employees, no matter their background. AHC does not discriminate in employment opportunities or practices on the basis of race, ethnicity, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, pregnancy and related medical conditions, protected veteran status, or any other characteristic protected by law. Adventist HealthCare will make reasonable accommodations for applicants with disabilities, in accordance with applicable law. Adventist HealthCare is a religious organization as defined under applicable law; however, it will endeavor to provide reasonable accommodations for applicants' religious beliefs. Applicants who wish to request accommodations for disabilities or religious belief should contact the Support Center HR Office.

Posted 30+ days ago

Research Scholar (Post-Doctoral Scholar)-logo
Research Scholar (Post-Doctoral Scholar)
Veterans Health Research InstituteSan Francisco, CA
Position Definition: This announcement is for a post-doctoral position in lab of Raymond Swanson, Dept. of Neurology, University of California, San Francisco ( https://www.swansonlab.com/index.html ). (The NCIRE "research scholar" position is equivalent to a post-doctoral fellow, and comes with all the resources available to UCSF post-doctoral fellows.) We are seeking a highly motivated individual to join a small, dedicated group with a focus on translational neuroscience. The incumbent will advance research relevant to Parkinson's disease therapeutics using cell culture, iPSC, and animal models of these disorders. The scholar will lead a research project involving a "gain of function" property of α-synuclein aggregates that presents a novel therapeutic avenue. The scholar will also participate in a project using CRISPR-edited human iPSC - derived dopaminergic neurons to evaluate specific gene variants that render individuals more susceptible to certain environmental causes of Parkinson's disease. Experience with fluorescence microscopy, histology, and immunohistochemistry is strongly preferred. Competitive candidates will have excellent communication and organizational skills and enjoy working with a variety of experimental approaches. Essential Functions: Using iPSC-derived neurons, identify genes that modulate susceptibility to toxicant-induced Parkinson's disease Assist in animal studies using AAV- mediated gene downregulation to identify genes that modulate susceptibility to toxicant-induced Parkinson's disease Use live-cell fluorescence microscopy Using cell culture preparations, identify peptides that mitigate the toxicity of alpha-synuclein aggregates. Data analysis and manuscript preparation related to the above. Job Requirements: PhD in Neuroscience or related filed Track record of first-author scientific publications Good familiarity with basic science of neurodegenerative disorders. Experience fluorescence microscopy, preferably live cell imaging Experience with cell culture and immunohistochemistry Excellent communication/collaboration/organizational skills Working Conditions/Environment: The work environment for this position will include an indoor office and a medical research environment. It may include some minor annoyances such as noise, temperature variations, etc. The incumbent may sustain posture in standing or seated position and may utilize a computer terminal for prolonged periods of time. The base wage range for this position is $68,640.00 - $79,639.96 per year. Salary and rank will commensurate with the candidate's qualifications and experience. The wage actually offered to a successful candidate will take into account various relevant and non-discriminatory business factors including, without limitation, the candidate's geographic location, job-related experience, knowledge, and skills, and education, as well as internal equity considerations. A successful candidate may also be eligible to earn additional compensation including bonuses. The Northern California Institute for Research and Education (NCIRE) is an Equal Employment Opportunity Employer. NCIRE is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, medical condition, physical or mental disability, Veteran status, sexual orientation, or any other characteristic protected under federal and state law, and to make all employment decisions based on merit, qualifications, and abilities. We are committed to furthering the principle of equal employment opportunity. NCIRE actively works to attract and retain talented individuals. NCIRE offers career opportunities in research and administration in pursuit of furthering medical research for our nation's Veterans.

Posted 5 days ago

Fall 2025 Post Doctoral Fellow - Cell Culture Development-logo
Fall 2025 Post Doctoral Fellow - Cell Culture Development
SanofiBoston, MA
Job Title: Postdoctoral Associate, Cell Culture Development Duration: Fixed Term Contract End Date: September 1, 2027 Location: Framingham, MA, Boston, Ma Cambridge, MA About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. We are seeking a curious, driven and collaborative postdoctoral scientist to join our Commercial Cell Culture Development team within Sanofi's Mammalian Platform. The successful candidate will work closely with the Cell Science and Technology team, whose mission is to optimize Sanofi's stable cell line Chinese Hamster Ovary (CHO) expression platform. This role will support a cross-functional project aimed at advancing the development and production of complex biologics through innovative approaches in cell line engineering, high-resolution imaging, and computational analysis. The ideal candidate will bring a strong foundation in mammalian cell culture and molecular biology, along with a keen interest in applying data science and machine learning to biological systems. This is a unique opportunity to contribute to cutting-edge research while mentoring junior scientists and working in a fast-paced, interdisciplinary environment. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Develop and optimize image-based assays to assess cellular phenotypes, protein localization and quality Analyze large-scale biological datasets using statistical and machine learning approaches Apply computational tools and custom scripts to process, visualize, and interpret experimental data Design and generate stable CHO cell lines expressing candidate biotherapeutics using various integration strategies Perform molecular and phenotypic characterization of engineered cell lines Collaborate with cross-functional teams to integrate experimental and computational insights into cell line and molecule development strategies Provide mentorship and technical guidance to junior scientists and research associates involved in the project. Maintain accurate and detailed experimental records, and contribute to internal reports, presentations, and publications Stay current with relevant scientific literature and emerging technologies in cell engineering, imaging, and computational biology Mentor junior scientists About You Basic Qualifications: Must have a PhD in Biology, Computational Biology, Bioengineering, Chemical Engineering, or a related field (0-3 years of postdoctoral experience). Proficiency in programming languages commonly used in bioinformatics and data science (e.g., Python, R) Must be able to relocate to the office location and work 40hrs/week, Monday-Friday Familiarity with image analysis techniques, processing pipelines, and feature extraction methods (e.g., CellProfiler, ImageJ, deep learning-based segmentation/classification). Familiarity with machine learning frameworks (e.g., scikit-learn, TensorFlow, PyTorch) and data analysis libraries (e.g., pandas, NumPy, seaborn). Hands-on experience with mammalian cell culture, including aseptic technique. Basic proficiency in molecular biology techniques such as fluorescent protein tagging, immunocytochemistry, PCR, and DNA/RNA isolation. Strong understanding of statistics and data visualization. Self-motivated with excellent attention to detail and superb organizational skills. Ability to thrive in an agile, fast-paced research environment. Strong communication and documentation skills, with the ability to work both independently and collaboratively. Preferred Qualifications: Experience with bioreactor operations at any scale (benchtop, pilot plant, or GMP). Demonstrated ability to analyze large biological datasets (e.g., RNA-seq, imaging data, proteomics). Familiarity with CHO cell line development and biotherapeutic protein expression. Basic proficiency in mammalian cell line engineering (e.g., transfection, selection, and generation of stable cell lines). Experience developing image-based assays and working with fluorescence microscopy. Experience with fluorescence microscopy, confocal microscopy or high-content imaging platforms Experience applying machine learning techniques to biological datasets, integrating multi-modal datasets, or developing predictive models Must have permanent US work authorization Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. The salary for this position is $95,000 annually. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through LINK. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Posted 1 day ago

Manager - Post Market Quality (Kennesaw, GA)-logo
Manager - Post Market Quality (Kennesaw, GA)
Artivion, Inc.Kennesaw, GA
Company Overview: Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com. Position Overview: The Manager of Post Market Quality will manage and maintain the Postmarket Surveillance (PMS) Program, including Complaint Handling, Adverse Event Reporting, Customer Feedback, Field Actions, and Health Risk Assessment. Will ensure compliance to U.S. and international regulations regarding the reporting of adverse events and product complaints. Responsibilities: Maintain compliance for the regulatory requirements relating to Complaint Handling, Adverse Event Reporting, including management of staff and resources assigned to handle these activities. Manage the Post-Market Surveillance Program. This includes timely compilation of all Post Market Surveillance Plans and Reports for all products manufactured by the Kennesaw and Austin facilities. Oversee the generation and assure appropriate distribution of Post-Market Surveillance track and trend data. Assure management is made aware of potential trends in a timely manner. Manage recall activities. Assure timely regulatory reporting of recall activities. Manage the generation and distribution of field safety notices. Manage the Customer Feedback program. Manage the activity of and develop the skills of the staff for Field Assurance. Design workflows and implement processes and procedures to ensure timely completion of reports and compliance in areas of responsibility. Conduct final review of complaint files, including but not limited to complaint summaries, coding incidents for appropriate conclusions and external/interdepartmental reports. Ensure MDR (Medical Device Reporting) forms, Canadian, Australian, and Tier II country, or applicable country adverse events forms are submitted in a timely manner. Recognize, evaluate and interpret complaint trends, will participate on design review teams/product and process improvement teams, and provide interactive feedback for improved safety, usability and labeling. Liaise with Clinical Affairs, Quality Systems, Regulatory Affairs and other departments as necessary to ensure appropriate monitoring of post market data. Participate in regulatory inspections and internal/external audits as appropriate. Ensure interface throughout the product realization process and during the entire product life cycle including post market-surveillance. Perform/coordinate in-depth investigations to include, where possible, root cause analysis for situations identified to be product complaints. Be knowledgeable on all applicable standards, regulations and procedures related to tissues and devices, both internally and externally. Keep informed and communicate significant changes/updates to regulations regarding the handling and investigation of complaints, adverse event reporting. Qualifications: Bachelor's Degree, preferably in the Life Science or engineering field. Minimum of 5 years' experience in an FDA regulatory industry with knowledge of ISO, FDA, the Quality System Regulations, MDD, MDR(EU) 2017/745. Must be able to maintain a high energy level and be able to prioritize, manage and follow up on numerous projects. Effective communication skills, both oral and written. Ability to communicate and interface with people at all levels. Must be detailed orientated and exhibit a high degree of flexibility and initiative. Must have a strong understanding of human physiology and surgical protocols relating to the use of Artivion products. Will require up to 10% travel. This is a hybrid position based out of our Corporate HQ in Kennesaw, GA. Candidate must be willing to commute to Kennesaw 2-3 days per week.

Posted 30+ days ago

Post-Silicon Engineer-logo
Post-Silicon Engineer
MarvellWestborough, MA
About Marvell Marvell's semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier architectures, our innovative technology is enabling new possibilities. At Marvell, you can affect the arc of individual lives, lift the trajectory of entire industries, and fuel the transformative potential of tomorrow. For those looking to make their mark on purposeful and enduring innovation, above and beyond fleeting trends, Marvell is a place to thrive, learn, and lead. Your Team, Your Impact At Marvell, we believe that infrastructure powers progress. That execution is as essential as innovation. That better collaboration builds better technology. Trusted by the world's leading technology companies for 25 years, we move, store, process and secure the world's data with semiconductor solutions designed for our customers' current needs and future ambitions. Through a process of deep collaboration and transparency, we're ultimately changing the way tomorrow's enterprise, cloud, automotive, and carrier architectures transform-for the better. The data infrastructure that our customers build has never been more critical to our global economy. It's what's keeping the world connected, businesses running, and information flowing. If you're ready to excel, innovate, and truly enjoy your work, apply now for the position detailed below. What You Can Expect The Opportunity Electrical Characterization Post-Silicon Engineer responsible for: Work with others in development and execution of Post-silicon Electrical tests required to validate that complex SOC devices conform to Electrical specifications Participate in the development and design of automation methods required for improving the efficiency of Electrical Characterization tests for complex SOC devices Debug issues related to new products to isolate design, test setup and specification issues. Interact as needed with IP, Analog, RTL, firmware/SW and other teams to identify requirements for Electrical Characterization efforts and to debug and resolve issues What We're Looking For Minimum Requirements Bachelor's degree in Electrical Engineering or related fields with 1+ years of work experience Experience with scripting languages (Python preferred) and oscilloscopes Good troubleshooting, analysis and problem-solving skills Strong communication skills, ability to clearly communication with teams around the world Must be willing to work in a multi-tasking, fast pace, and team-oriented work environment Expected Base Pay Range (USD) 98,000 - 144,970, $ per annum The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions. Additional Compensation and Benefit Elements At Marvell, we offer a total compensation package with a base, bonus and equity.Health and financial wellbeing are part of the package. That means flexible time off, 401k, plus a year-end shutdown, floating holidays, paid time off to volunteer. Have a question about our benefits packages - health or financial? Ask your recruiter during the interview process. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status. Any applicant who requires a reasonable accommodation during the selection process should contact Marvell HR Helpdesk at TAOps@marvell.com. #LI-TT1

Posted 1 week ago

UM Manager, Inpatient And Post Acute Services (Monday - Friday)-logo
UM Manager, Inpatient And Post Acute Services (Monday - Friday)
PacificsourceHelena, MT
Looking for a way to make an impact and help people? Join PacificSource and help our members access quality, affordable care! PacificSource is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status, such as race, religion, color, sex, sexual orientation, gender identity, national origin, genetic information or age. PacificSource values the diversity of our community, including those we hire and serve. We are committed to creating and fostering a work environment in which individual differences and diversity are appreciated, respected and responded to in ways that fully develop and utilize each person's talents and strengths. The Manager of Utilization Management (UM) for Inpatient, Post-Acute and Dual Eligible Special Needs (DSN oversees and directs the utilization management process for inpatient admissions, post-acute care services, and DSNP members). This role ensures compliance with regulatory requirements, optimizes quality and cost-effectiveness, and facilitates coordinated care across the care continuum. The Manager works closely with interdisciplinary teams to achieve organizational goals and high standards of member-centric care and is integrally involved in the Health Services (HS) program development, implementation, and strategic planning. Qualified candidates must be acceptable to the following available work schedule: Monday - Friday 8:00am to 5:00pm Essential Responsibilities: Oversee daily UM operations for inpatient services including clinical review, authorization, and concurrent review processes to ensure efficient and effective utilization management. Ensure timely level of care determinations alignment with clinical guidelines and regulatory requirements to ensure patients receive the right care at the right time. Collaborate with hospital case managers, providers, and interdisciplinary teams to facilitate safe and cost-effective discharge plans for patients. Monitor and track and analyze inpatient length of stay metrics, readmissions, key performance indicators (KPIs), and turnaround times to identify areas for improvement. Oversee utilization review for skilled nursing facilities, home health, long-term acute care, and other post-acute settings to ensure appropriate care. Establish effective transitions of care with post-acute providers to reduce preventable readmissions and promote optimal member outcomes. Use evidence-based protocols to ensure medical necessity for continued stays and manage cost-effectiveness in the post-acute phase. Provide leadership and direction for Dual-Eligible Special Needs Plan (DSNP) utilization management, ensuring integration of Medicare and Medicaid requirements. Work closely with care coordination teams to address the unique needs of DSNP enrollees, including social determinants of health. Ensure compliance with state and federal regulations and DSNP contractual obligations, including timely authorization and appeals processes. Develop, implement, and regularly update policies and procedures to ensure compliance and best practices in utilization management. Prepare for and manage internal and external audits pertaining to UM and DSNP activities to ensure compliance and readiness. Work closely with the UM Director to facilitate the development and implementation of new programs and support ongoing success of department goals and initiatives. Directly supervise the UM inpatient team, along with staff focused on post-acute and DSNP reviews, ensuring effective team performance. Recruit, train, and mentor clinical reviewers, nurses, coordinators, and other UM personnel to build a skilled and knowledgeable team. Conduct performance evaluations, set goals, and foster professional development to maintain a high-performing team. Attend continuing education events: Attend continuing education events to ensure that PacificSource UM programs maintain current industry best practices. Develop and monitor the annual department budget: Develop the annual department budget, monitor spending versus the approved budget throughout the year, and take corrective action where needed. Responsible for process improvement and collaboration with other departments to improve interdepartmental processes using Lean methodologies, visual boards, and daily huddles to monitor KPIs and identify improvement opportunities. Actively participate as a key team member in Manager/Supervisor meetings to discuss and address departmental and organizational issues. Actively participate in various strategic internal and external committees to disseminate information and represent company philosophy. Develop and track metrics to evaluate utilization trends, authorization outcomes, readmission rates, and other key performance indicators, presenting monthly/quarterly dashboards and reports to senior leadership with actionable insights for continuous improvement. Supporting Responsibilities: Serve as back up to the Director of Utilization Management, as needed Meet department and company performance and attendance expectations. Follow the PacificSource privacy policy and HIPAA laws and regulations concerning confidentiality and security of protected health information. Perform other duties as assigned. SUCCESS PROFILE Work Experience: Minimum of seven (7) years of clinical experience required and a minimum of 3 years direct health plan experience in case management, utilization management, or disease management. Prior supervisory or management experience required. Education, Certificates, Licenses: Registered Nurse or Licensed Clinical Social Worker with current appropriate state licenses. Certified Case Manager Certification as accredited by CCMC preferred. Knowledge:Thorough knowledge and understanding of medical procedures, diagnoses, care modalities, procedure codes, including ICD-9 & 10, CPT codes, health insurance and State of Oregon mandated benefits. Knowledge of managed care products and third-party liability (TPL) is required. Ability to develop, review and evaluate utilization and case management reports. Knowledge of health insurance and State mandated benefits experience in adult education preferred. Competencies Building Trust Building a Successful Team Aligning Performance for Success Building Partnerships Customer Focus Continuous Improvement Decision Making Facilitating Change Leveraging Diversity Driving for Results Environment: Work inside in a general office setting with ergonomically configured equipment. Travel is required approximately 10% of the time. Skills: Accountable leadership, Collaboration, Communication, Data-driven & Analytical, Delegation, Listening (active), Situational Leadership, Strategic Thinking Our Values We live and breathe our values. In fact, our culture is driven by these seven core values which guide us in how we do business: We are committed to doing the right thing. We are one team working toward a common goal. We are each responsible for customer service. We practice open communication at all levels of the company to foster individual, team and company growth. We actively participate in efforts to improve our many communities-internally and externally. We actively work to advance social justice, equity, diversity and inclusion in our workplace, the healthcare system and community. We encourage creativity, innovation, and the pursuit of excellence. Physical Requirements: Stoop and bend. Sit and/or stand for extended periods of time while performing core job functions. Repetitive motions to include typing, sorting and filing. Light lifting and carrying of files and business materials. Ability to read and comprehend both written and spoken English. Communicate clearly and effectively. Disclaimer: This job description indicates the general nature and level of work performed by employees within this position and is subject to change. It is not designed to contain or be interpreted as a comprehensive list of all duties, responsibilities, and qualifications required of employees assigned to this position. Employment remains AT-WILL at all times.

Posted 30+ days ago

Director Of Product, Post Order-logo
Director Of Product, Post Order
XometryNorth Bethesda, MD
Xometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies to tap into global manufacturing capacity. Are you a visionary product leader passionate about revolutionizing the post-order experience? Do you excel in a dynamic environment, collaborating with top-tier product teams to achieve ambitious milestones? If you're a seasoned B2B product leader with a history of delivering exceptional results, Xometry's Director of Product, Post Order role might be the perfect opportunity! In this critical role, you will define and execute the strategic vision for Xometry's post-order product suite, driving the development of innovative solutions that enhance customer satisfaction and streamline operations. What You'll Do: Define the product vision and roadmap for Xometry's post-order products, ensuring alignment with business strategy and market opportunities. Collaborate with engineering, design, operations, and customer service to deliver seamless post-order experiences. Conduct in-depth analysis to understand customer post-order needs and identify opportunities for improvement. Develop and implement post-order product launch strategies, ensuring successful execution. Own the post-order product lifecycle, driving continuous enhancement based on feedback and data. Utilize analytics to measure and optimize post-order product performance. Stay informed about industry trends in post-order management and logistics. Oversee the development of documentation and support materials for post-order processes. What You Need To Be Successful in The Role: 10+ years of experience in product management, with 3-5 years leading product development teams. Strong business acumen to manage post-order business outcomes. Proven track record of successfully launching and scaling B2B post-order solutions. Excellent leadership and communication skills to collaborate effectively with teams. Experience building high-performing product teams in a fast-growth environment. Strong analytical skills and a data-driven approach to decision-making. Ability to translate customer feedback into actionable post-order strategies. Executive presence and the ability to communicate post-order vision to stakeholders. Understanding of post-order processes, logistics, and customer service. Experience managing product roadmaps for post-order or related enterprise software. Experience working in a fast-paced, growth-oriented company. #LI-Hybrid Xometry is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. For US based roles: Xometry participates in E-Verify and after a job offer is accepted, will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Posted 30+ days ago

Clinical Nurse III - C6: Post-Surgical Short Stay-logo
Clinical Nurse III - C6: Post-Surgical Short Stay
Albany Medical Health SystemAlbany, NY
Department/Unit: Short Stay Surgical Work Shift: Night (United States of America) Salary Range: $76,396.32 - $126,730.61 Clinical Nurse Job Description Summary The clinical Nurse contributes to the creation of a compassionate and caring environment for patients, families and colleagues through displays of kindness and active listening. Recognizes and appreciates that each employee's work is valuable and contributes to the success of the Mission. Job Description Implements physician orders, administers medications, starts IVs, performs treatments, procedures and special tests, and document treatment as required by company policy and local/state/federal rules and regulations. Orders, interprets, and evaluates diagnostic tests to identify and assess patients' conditions. Assesses and evaluates patient needs for, and responses to, care rendered. Applies sound nursing judgment in patient care management decisions. Provides primary and emergency care for occupational and non-occupational injuries and illnesses. Administers over-the-counter and prescription medications as ordered. Collaborates with the nursing team to create a Plan of Care for all patients. Directs and guides ancillary personnel and maintain standards of professional nursing. Minimum Qualifications Graduate of a professional academic nursing program in which a Diploma, Associate Degree or Baccalaureate Degree is conferred Must hold current NYS Registered Nurse license Obtains and maintains certification in Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) Minimum of 1-3 years of previous clinical RN experience in Med-Surg or Progressive Care Excellent communication, prioritization, organizational and time-management skills Possesses knowledge of quality concepts, principles, and problem-solving tools and techniques and demonstrates ability to apply in support of departmental and patient care quality improvement Clinical Nurse Job Description Summary The clinical Nurse contributes to the creation of a compassionate and caring environment for patients, families and colleagues through displays of kindness and active listening. Recognizes and appreciates that each employee's work is valuable and contributes to the success of the Mission. Job Description Implements physician orders, administers medications, starts IVs, performs treatments, procedures and special tests, and document treatment as required by company policy and local/state/federal rules and regulations. Orders, interprets, and evaluates diagnostic tests to identify and assess patients' conditions. Assesses and evaluates patient needs for, and responses to, care rendered. Applies sound nursing judgment in patient care management decisions. Provides primary and emergency care for occupational and non-occupational injuries and illnesses. Administers over-the-counter and prescription medications as ordered. Collaborates with the nursing team to create a Plan of Care for all patients. Directs and guides ancillary personnel and maintain standards of professional nursing. Minimum Qualifications Graduate of a professional academic nursing program in which a Diploma, Associate Degree or Baccalaureate Degree is conferred Must hold current NYS Registered Nurse license Obtains and maintains certification in Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) Minimum of 1-3 years of previous clinical RN experience in Med-Surg or Progressive Care Excellent communication, prioritization, organizational and time-management skills Possesses knowledge of quality concepts, principles, and problem-solving tools and techniques and demonstrates ability to apply in support of departmental and patient care quality improvement Thank you for your interest in Albany Medical Center! Albany Medical is an equal opportunity employer. This role may require access to information considered sensitive to Albany Medical Center, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that: Access to information is based on a "need to know" and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.

Posted 30+ days ago

RN - Pre/Post Surgicenter-logo
RN - Pre/Post Surgicenter
Carle Foundation HospitalChampaign, IL
Overview The staff Registered Nurse (RN) is a professional caregiver who assumes responsibility for a group of patients for a designated time frame and provides care to these patients via the utilization of the nursing process, nursing trends, technology, financial and human resources within the philosophy of the institution. Qualifications Certifications: Advanced Cardiac Life Support (ACLS) within 1 year- American Heart Association (AHA); Licensed Registered Professional Nurse (RN) - Illinois Department of Financial and Professional Regulation (IDFPR); Basic Life Support (BLS) within 30 days- American Heart Association (AHA), Education: Diploma: Nursing (Required), Work Experience: Responsibilities Performs all responsibilities and duties required by unit as specific to the scope of service. Implements procedures and theories related to the specific area of practice. Maintains up-to-date and accurate documentation of nursing care provided to assure the integration of information for use by the healthcare team. Completes initial assessment upon patient admission and develops appropriate plan of care in accordance with unit standards and that is based on patient and family needs. Implements plan of care, nursing interventions, and patient care procedures. Modifies plan of care based upon continuous evaluation. Takes responsibility for patient and employee safety by reporting and/or correcting safety hazards and incidents. Communicates with others directly and in private when necessary to resolve issues. Offers constructive feedback to assist in the professional development of peers and confers with colleagues to expand knowledge base. Identifies own learning needs and takes initiative to begin appropriate solution. Fulfills all requirements of departmental competencies. About Us Find it here. Discover the job, the career, the purpose you were meant for. The supportive and inclusive team where you can thrive. The place where growth meets balance - and opportunities meet flexibility. Find it all at Carle Health. Based in Urbana, IL, Carle Health is a healthcare system with nearly 16,600 team members in its eight hospitals, physician groups and a variety of healthcare businesses. Carle BroMenn Medical Center, Carle Foundation Hospital, Carle Health Methodist Hospital, Carle Health Proctor Hospital, Carle Health Pekin Hospital, and Carle Hoopeston Regional Health Center hold Magnet designations, the nation's highest honor for nursing care. The system includes Methodist College and Carle Illinois College of Medicine, the world's first engineering-based medical school, and Health Alliance. We offer opportunities in several communities throughout central Illinois with potential for growth and life-long careers at Carle Health. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Carle Health participates in E-Verify and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization. | For more information: human.resources@carle.com. Compensation and Benefits The compensation range for this position is $30.62per hour - $52.67per hour. This represents a good faith minimum and maximum range for the role at the time of posting by Carle Health. The actual compensation offered a candidate will be dependent on a variety of factors including, but not limited to, the candidate's experience, qualifications, location, training, licenses, shifts worked and compensation model. Carle Health offers a comprehensive benefits package for team members and providers. To learn more visit careers.carlehealth.org/benefits.

Posted 1 week ago

Post Doctoral Research Fellow-Theresa Lu Lab-logo
Post Doctoral Research Fellow-Theresa Lu Lab
Hospital For Special SurgeryNew York, NY
How you move is why we're here. Now more than ever. Get back to what you need and love to do. The possibilities are endless... Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize the abundant opportunities for growth and success. If this describes you then let's talk! HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment. Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise. Emp Status Regular Full time Work Shift Day (United States of America) Compensation Range The base pay scale for this position is $68,811.60 - $75,010.00. In addition, this position will be eligible for additional benefits consistent with the role. The salary of the finalist selected for this role will be determined based on various factors, including but not limited to: scope of role, level of experience, education, accomplishments, internal equity, budget, and subject to Fair Market Value evaluation. The hiring range listed is a good faith determination of potential compensation at the time of this job advertisement and may be modified in the future. What you will be doing Title: Postdoctoral Fellow- Dr. Theresa Lu Lab Department/Service: Research Institute- Autoimmunity and Inflammation Program Job Start Date: May 2025 JOB DESCRIPTION The Lu Lab has a new postdoc position open for a motivated individual looking to develop and lead a project examining how inflammatory skin responses in lupus regulates the stromal microenvironment and immunity in draining lymph nodes. Please see our papers and our recently accepted manuscript ( https://www.biorxiv.org/content/10.1101/2022.06.13.495930v3.full ), and learn more about us from our website TheresaLuLab.com and Theresa Lu's LinkedIn profile. We are at the Hospital for Special Surgery Research Institute, part of the renowned Hospital for Special Surgery, a specialized Rheumatology and Orthopedics hospital that is top ranked by US World and New Report. We also belong to the Weill Cornell Medical School in New York City and an active part of the Weill Cornell Immunology and Microbial Pathogenesis graduate program. Interested applicants should have a PhD, MD, or MD-PhD and should send CV and names of three references to Dr. Lu at LuT@HSS.edu or THL2005@med.cornell.edu. EDUCATION REQUIRED Successful candidates will have a Ph.D. or M.D. degree, a background in cellular and molecular immunology, a strong work ethic, and the ability to work independently. High level of motivation and the ability to think critically are expected. SKILLS REQUIRED Proficient in the use of computers and software, including Microsoft Excel and Word. Technical proficiency and ability to work independently. Analytical skills. SKILLS PREFERRED Knowledge of Orthopedic and/or Rheumatologic terminology is a plus. Non-Discrimination Policy Hospital for Special Surgery is committed to providing high quality care and skilled, compassionate, reliable service to our community in a safe and healing environment. Consistent with this commitment, Hospital for Special Surgery provides care, admits, and treats patients and provides all services without regard to age, race, color, creed, ethnicity, religion, national origin, culture, language, physical or mental disability, socioeconomic status, veteran or military status, marital status, sex, sexual orientation, gender identity or expression, or any other basis prohibited by federal, state, or local law or by accreditation standards.

Posted 30+ days ago

Clinical Nurse - Bell Pre/Post | Part-Time-logo
Clinical Nurse - Bell Pre/Post | Part-Time
The University Of Kansas HospitalKansas City, KS
Position Title Clinical Nurse- Bell Pre/Post | Part-Time Bell Hospital Position Summary / Career Interest: The Clinical Nurse in the Pre/Post department provides professional nursing care through assessment and accurate documentation, diagnosis, planning, implementation and evaluation for the comfort and well-being of patients. Carries out a plan of care specific to unit competencies for the target patient population. Coordinates care delivery and education through collaboration with patient, family and all health care team providers to ensure safe, effective and quality patient care. Follows organizational policies in providing safe patient care. Performs other duties as assigned. Variety of part-time and full-time night weekend shifts. Some shifts will offer a premium. Responsibilities and Essential Job Functions Provides professional nursing care through assessment and accurate documentation, diagnosis, planning, implementation and evaluation for the comfort and well-being of patients. Carries out a plan of care specific to unit competencies for the target patient population. Coordinates care delivery and education through collaboration with patient, family and all health care team providers to ensure safe, effective and quality patient care. Follows organizational policies in providing safe patient care. Must be able to perform the professional, clinical and or technical competencies of the assigned unit or department. These statements are intended to describe the essential functions of the job and are not intended to be an exhaustive list of all responsibilities. Skills and duties may vary dependent upon your department or unit. Other duties may be assigned as required. Required Education and Experience High School Graduate Associate Degree Nursing For ADN prepared nurses hired after February 24, 2017, must complete BSN degree by the fifth anniversary of employment as an RN with UKHA 2 or more years experience as a Clinical Nurse Preferred Education and Experience Bachelor Degree Nursing Required Licensure and Certification Licensed Registered Nurse (LRN)- Single State- State Board of Nursing (Kansas) or compact license Basic Cardiac Life Support (BLS or BCLS) - American Heart Association (AHA) within 14 days Time Type: Part time Job Requisition ID: R-2915 We are an equal employment opportunity employer without regard to a person's race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, ancestry, age (40 or older), disability, veteran status or genetic information. Need help finding the right job? We can recommend jobs specifically for you! Create a custom Job Alert by selecting criteria that suit your career interests.

Posted 30+ days ago

Post Doctoral Associate (Neurological Surgery)-logo
Post Doctoral Associate (Neurological Surgery)
University Of Miami Miller School Of MedicineMiami, FL
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet. The University of Miami/UHealth Sylvester Comprehensive Cancer Center is currently seeking a full time Post Doctoral Associate to work in Miami, FL. The Post Doctoral Associate performs scientific research and studies under the supervision of managing staff. Moreover, the Post Doctoral Associate promotes institutional recognition through literal contributions to the scientific community CORE JOB FUNCTIONS Conducts research on specific areas of study as assigned. Prepares research reports and technical papers for publishing. Investigates the feasibility of applying a wide variety of scientific principles and theories. Maintains substantial knowledge of state-of-the-art principles and theories. Develops advanced analytical models and systems and provides solutions and analyses to support strategic and tactical decisions. Adheres to University and unit-level policies and procedures and safeguards University assets. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. CORE QUALIFICATIONS Education: Ph.D. required Experience: No prior experience required Knowledge, Skills and Attitudes: Skill in collecting, organizing, and analyzing data. Ability to recognize, analyze, and solve a variety of problems. Ability to exercise sound judgment in making critical decisions. The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for. The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information. Job Status: Full time Employee Type: Staff Pay Grade: A9

Posted 30+ days ago

Post Doctoral Associate-logo
Post Doctoral Associate
University of Miami Miller School of MedicineMiami, FL
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet. The Pathology Department at the University of Miami has an exciting opportunity for a Post Doctoral Associate. SUMMARY The Post Doctoral Associate performs scientific research and studies under the supervision of managing staff. Moreover, the Post Doctoral Associate promotes institutional recognition through literal contributions to the scientific community. CORE JOB FUNCTIONS Conducts research on specific areas of study as assigned. Prepares research reports and technical papers for publishing. nvestigates the feasibility of applying a wide variety of scientific principles and theories. Maintains substantial knowledge of state-of-the-art principles and theories. Develops advanced analytical models and systems and provides solutions and analyses to support strategic and tactical decisions. Adheres to University and unit-level policies and procedures and safeguards University assets. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. CORE QUALIFICATIONS Education: MD or Ph.D. in relevant field Experience: Previous postdoctoral experience preferred Knowledge, Skills and Attitudes: Skill in collecting, organizing, and analyzing data. Ability to recognize, analyze, and solve a variety of problems. Ability to exercise sound judgment in making critical decisions. Experience with serological techniques (gel electrophoresis, Western blot, ELISA), PCR, flow cytometry Department Specific Functions Work with the PI to define areas of study in exotic and wildlife species. Work independently on projects including database creation as well as a laboratory techniques including western blot, ELISA, gel electrophoresis, quantitative enzyme assays, and flow cytometry as well as projects involving core laboratories including mass spectrometry. Presentation of studies at national meetings. Overview of laboratory test development with a focus in antibody and antigen detection. The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for. The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information. Job Status: Full time Employee Type: Staff Pay Grade: A9

Posted 2 weeks ago

Post Trade Software Engineer-logo
Post Trade Software Engineer
PDT PartnersNew York, NY
Post Trade owns the platform that routes and manages all of our post-trade data, as well as the software that handles the intricate needs of our fund accounting and operations teams. Designing software tailored to those needs-related to trade data, expense allocation, and financing, to name a few-is a top business priority with clear, significant impact. Your systems will be used by nearly every team at the company. Successful candidates come from very strong technical and academic backgrounds, are interested in solving complex technical issues, wish to be deeply involved in hands-on programming. They also enjoy ownership of business-critical projects, working on the full life cycle of large complex systems, from designing and implementing new components and features to supporting and enhancing existing functionality. Why join us? PDT Partners has a stellar 30+ year track record and a reputation for excellence. Our goal is to be the best quantitative investment manager in the world-measured by the quality of our products, not their size. PDT's very high employee-retention rate speaks for itself. Our people are intellectually extraordinary, and our community is close-knit, down-to-earth, and diverse. Responsibilities: Understand and anticipate the software challenges faced by our fund accounting and operations teams, then engineer efficient, user-friendly solutions Lead the evolution of our post-trade technology stack for research, finance, risk, and compliance Help select, vet, and integrate open-source and third-party platforms Below is a list of skills and experiences we think are relevant. Even if you don't think you're a perfect match, we still encourage you to apply because we are committed to developing our people. 3-5+ years of professional software development experience Experience designing scalable and highly reliable software systems Familiarity with Linux, distributed systems programming, and multithreaded programming Significant experience programming in an object-oriented programming language Experience in and enthusiasm for scoping requirements and collaborating with colleague-clients Knowledge of, or interest in, trading and finance is beneficial Education: Bachelors or Masters degree in an Engineering or Applied Sciences field from a rigorous academic program or equivalent professional experience. The salary range for this role is between $195,000 and $225,000. This range is not inclusive of any potential bonus amounts. Factors that may impact the agreed upon salary within the range for a particular candidate include years of experience, level of education obtained, skill set, and other external factors. PRIVACY STATEMENT: For information on ways PDT may collect, use, and process your personal information, please see PDT's privacy notices.

Posted 5 days ago

Patient Care Technician - Post Anesthesia Care Unit (Pacu)-logo
Patient Care Technician - Post Anesthesia Care Unit (Pacu)
Sentara HealthcareNorfolk, VA
City/State Norfolk, VA Work Shift First (Days) Overview: The Patient Care Technician provides patient care, support independent and dependent activities of daily living, vital signs, mobility and ambulation, phlebotomy, point of care testing, EKG testing, peripheral IV removal, specimen collection, and foley catheter insertion and removal, and comply with patient safety practices under the direction of the professional RN nurse. Observe patients' physical, mental, and emotional conditions and document in a timely and accurate manner while reporting any change to the nurse or medical staff. Department Overview: Our 20-bay PACU is looking for a new or experienced Patient Care Technician! This fast-paced unit assists with all specialties in our Level I Trauma Center at Norfolk General. Education HS Diploma or Equivalent (Required) and one of the following required: Sentara Care Partner Certification Program, or Successful completion of the Certified Nursing Assistant (CNA), or National Certified Medical Assistant (NCMA), or National Patient Care Technician (NCPCT), or Completion of US Navy Hospital Corps School, or Emergency Services to include EMR, EMS, EMT, AEMT and Paramedic, or Current student enrolled in a clinical program (beyond prerequisites) having completed at least one semester of RN, LPN, RT or PT, or Current work experience within last three years as a PCT or Nursing Assistant. Certification/Licensure Basic Life Support Certification Keywords: NCP, Nursing Care Partner, CNA, Certified Nursing Assistant, Nursing Assistant, NA, Patient Care Tech, PCT, MA, Medical Assistant, EMT, EMS, Paramedic . Benefits: Caring For Your Family and Your Career Medical, Dental, Vision plans Adoption, Fertility and Surrogacy Reimbursement up to $10,000 Paid Time Off and Sick Leave Paid Parental & Family Caregiver Leave Emergency Backup Care Long-Term, Short-Term Disability, and Critical Illness plans Life Insurance 401k/403B with Employer Match Tuition Assistance - $5,250/year and discounted educational opportunities through Guild Education Student Debt Pay Down - $10,000 Reimbursement for certifications and free access to complete CEUs and professional development Pet Insurance Legal Resources Plan Colleagues may have the opportunity to earn an annual discretionary bonus if established system and employee eligibility criteria is met Here at Sentara, we are committed to consistently enhancing our training, advancement tracks, work-life benefits, and more. Our goal is to make you feel more excited to be here every day! Sentara Norfolk General Hospital, located in Norfolk, VA, is a 525-bed tertiary care facility that is home to the only Level I Adult Trauma Center and burn trauma unit in Hampton Roads, and also serves as the primary teaching hospital for Eastern Virginia Medical School. In addition to the high-quality heart program at Sentara Heart Hospital, our facility is home to Nightingale Regional Air Ambulance and several other dedicated facilities and specialized services. As a recognized accredited Comprehensive Stroke Center, and Magnet hospital for nursing excellence, our hospital specializes in heart and vascular, neurosciences, neurosurgery, urology, oncology, spine care, advanced imaging, behavioral health, maternity, and women's health, including a state-of-the-art neonatal intensive care unit. Sentara Health is an equal opportunity employer and prides itself on the diversity and inclusiveness of its close to an almost 30,000-member workforce. Diversity, inclusion, and belonging is a guiding principle of the organization to ensure its workforce reflects the communities it serves. In support of our mission "to improve health every day," this is a tobacco-free environment. For positions that are available as remote work, Sentara Health employs associates in the following states: Alabama, Delaware, Florida, Georgia, Idaho, Indiana, Kansas, Louisiana, Maine, Maryland, Minnesota, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.

Posted 1 week ago

Patient Care Tech - Post Surgical (Pct)-logo
Patient Care Tech - Post Surgical (Pct)
Deaconess Health SystemJasper, IN
Campus: Memorial Hospital and Health Care Center Unit: Post Surgical Shift:2:00 pm- 10:30 pm- EST Hours per Week: 36 Weekends: Every Other Holidays: 2 summer & 2 winter Incentives: Eligible for evening/night, weekend shift incentive based on company policies and applicable job codes. Additional details will be provided during the interview process. Benefits: We pride ourselves in retaining our top talent by offering work environments that support professional development and personal success. In addition to our robust healthcare and retirement plans, we offer: Flexible work schedules- Full time/part time/supplemental- Day/Eve/Night Tuition reimbursement Student Loan Repayment Program Payactiv - earned wage benefit-work today, get paid tomorrow Career advancement opportunities Job Overview: The Patient Care Tech assists professional nursing staff by performing supportive and complimentary tasks in patient care activities under direct supervision and in conjunction with the other team members. Performs routine Department duties and demonstrates knowledge of developmental needs of patient population specific to that Department. Required: Certifications/Licenses/Experience: Education: High School student, diploma, or equivalent required Preferred Certification/Licenses/Experience: Certified Nursing Assistant CPR Provider- C Previous experience in a health care facility Other Key Words: Medical, Medical Surgical, Student, Nursing Assistant, Certified Nursing Assistant, Post Surgical,

Posted 30+ days ago

Post-Doctoral Clinical Psychology Fellow-logo
Post-Doctoral Clinical Psychology Fellow
Boys TownOmaha, NE
Provides clinical services to children, adolescents and families seeking services at the Behavioral Health Clinic and possibly a primary care setting. This is a one-year position. MAJOR RESPONSIBILITIES & DUTIES: Provides behavioral health services to children, adolescents and families. Provides direct clinical services to clients as assigned. Helps to establish and maintain a referral base from pediatricians, local schools, other treatment providers, and general community referrals. Provides psychological services, behavior parent training, and other essential psychological services to parents and youth referred to the outpatient clinic or assigned co-location clinics. Provides consultation on an as-requested basis to referring pediatricians about general psychological phenomenon and how they may impact development, compliance, or other medical issues. Actively participates in supervision to meet requirements for licensure as a psychologist. Participates in weekly individual supervision meetings with a licensed psychologist. Increases knowledge of clinical psychology in related fields by continuing education and informal and formal discussions. KNOWLEDGE, SKILLS, AND ABILITIES: Familiarity with behavioral or cognitive behavioral theoretical orientation. Ability to communicate with individuals at all levels in the organization and with external contacts in an articulate, professional manner while maintaining necessary degree of confidentiality. High level of professionalism and interpersonal skills. REQUIRED QUALIFICATIONS: Ph.D. or Psy.D. in Psychology from an APA-accredited or its equivalent university. Advanced training in clinical psychology, behavioral pediatrics, and/or parent training required. Successful completion of an APA approved internship or its equivalent required. Licensure requirements at the master's level required. Graduate degree conferred by August 31 of internship year required. Licensed at the Master's level for the delivery of mental health services in the state of Nebraska required. License/registration to be required, based on state or jurisdiction. Other Duties: This job description incorporates the essential functions and duties required for this position. However, other duties may be required and assigned at times and as determined by a supervisor in order to meet the needs of the organization. Serves as a role model in carrying out activities and behaviors that reflect the values and principles of the Boys Town mission. PHYSICAL REQUIREMENTS, EQUIPMENT USAGE, WORK ENVIRONMENT: Position requires little to moderate physical activity. Handling of average weight objects up to 20 pounds, or standing and/or walking or at a keyboard, workstation, or desk. Requires endurance to perform during stressful (physical, mental and emotional) situations encountered on the job without compromising their health and well-being or that of their fellow employees, youth, or families. Work is typically in a normal office environment involving minimal exposure to physical risks. May be subject to outside environmental conditions occasionally. Includes constant interruptions, inappropriate behaviors, and the potential for verbal and physical threats from youth. Care and respect for others is more than a commitment at Boys Town - it is the foundation of who we are and what we do. At Boys Town, we cultivate a culture of belonging for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team - one that makes better decisions, drives innovation, and delivers better business results. About Boys Town: Boys Town has been changing the way America cares for children and families since 1917. With over a century of service, our employees have helped us grow from a small boardinghouse in downtown Omaha, Nebraska, into one of the largest national child and family care organizations in the country. With the addition of Boys Town National Research Hospital in 1977, our services branched out into the health care and research fields, offering even more career opportunities to those looking to make a real difference. Our employees are our #1 supporters when it comes to achieving Boys Town's mission, which is why we are proud of their commitment to making the world a better place for children, families, patients, and communities. A unique feature for employees and their dependents enrolled in medical benefits are reduced to no cost visits for services performed by a Boys Town provider at a Boys Town location. Additional costs savings for the employee and their dependents are found in our pharmacy benefits with low to zero-dollar co-pays on certain maintenance drugs. Boys Town takes your mental health seriously with no cost mental health visits to an in-network provider. We help our employees prepare for retirement with a generous match on their 401K or 401K Roth account. Additional benefits include tuition assistance, parenting resources from our experts and professional development opportunities within the organization, just to name a few. Working at Boys Town is more than just a job, it is a way of life. This advertisement describes the general nature of work to be performed and does not include an exhaustive list of all duties, skills, or abilities required. Boys Town is an equal employment opportunity employer and participates in the E-Verify program. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and/or expression, national origin, age, disability, or veteran status. To request a disability-related accommodation in the application process, contact us at 1-877-639-6003.

Posted 30+ days ago

Edwards Lifesciences Corp logo
Senior Manager, Clinical Product Quality - Post Market Quality & Complaints
Edwards Lifesciences CorpNorth Carolina, NC
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Job Description

This position offers the flexibility of being fully remote, but the selected candidate must be residing within the United States.

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Senior Manager, Clinical Product Quality will plan and lead initiatives around Post-Market Quality Assurance, specifically Complaint Handling, assuring appropriate investigation and documentation of product complaints, including reporting of events to regulatory Agencies. Provide Medical/Clinical Guidance to Complaint Staff and Engineers to understand the nature of complaints and possible health risks.

How you will make an impact:

  • Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, and required regulatory reporting (MDR, MDV, etc.).
  • Review and approve global reporting decisions, MDRS/MIRs prior to submission, and complaints for closure.
  • Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution.
  • May provide training to complaint staff on patient anatomy and medical conditions, products and

procedure, and internal policies and procedures.

  • Develop and plan Medical/Clinical Guidance projects and activities with accountability for successful completion of all project deliverables.
  • Educates complaint staff to understand nature of complaints and possible health risks; Interprets complaint data for Quality compliance staff, complaint investigators and other Quality department personnel.
  • Authors clinically based product specific scripts to guide complaint handlers in appropriate investigation.
  • Provide Clinical input for quality escalations, risk assessments, nonconformances and CAPAs.
  • Provide direction and guidance to project teams to execute tactical clinical product quality projects and/or initiatives.

Identify and evaluate clinical product quality process improvement and/or course correction/course alignment opportunities, including owning nonconformances and CAPAs.

  • Documents and maintains complaint coding and reportability decisions to Global Regulatory Authorities. Coding and reporting decisions are documented and maintained in the Complaint Coding and Reportability Matrix and utilized as guidance by the Post-Market QA Team for complaints investigations.
  • In aggregate, analyzes and interprets complaint data and prepares responses to external requests (i.e. regulatory agency requests) or internal requests (i.e. regulatory submission support, R&D product development or quality investigation support). Analyze and present complaint trend data at Management review, recommend areas for additional review or investigation.
  • Performs imaging reviews with clinicians, determines root cause of the reported events, and writes a final report in order to satisfy regulatory investigational requirements.
  • Other duties assigned by leadership

What you'll need (Required Qualifications):

  • Bachelor's degree in nursing, scientific, or quality related field plus a minimum of 10 years of relevant experience; or a Master's degree in nursing, scientific, or quality related field plus a minimum of 8 years of relevant experience.
  • Medical device industry, quality systems, or hospital/clinical experience (e.g. cath lab, cardiac care, ICU, OR, or cardiovascular/endovascular interventions). Combination of nursing, quality and/or medical device industry experience is a strong plus.
  • Supervisory or people leadership experience.
  • Registered nurse with current state license in good standing

What else we look for (Preferred Qualifications):

  • Demonstrated ability to lead and manage a team.
  • Proven experience with complaint handling and managing MDR (Medical Device Reporting).
  • Extensive experience with CAPAs, NCRs, and Failure Analysis.
  • Medical Device (cardiovascular, endovascular, or other critical care/surgical products)
  • Strong understanding of risk management principles and practices.
  • Proficiency in interpreting and analyzing clinical complaint data.
  • Strong analytical skills with the ability to identify trends and conduct root cause analysis/investigations.
  • Proven successful project management skills
  • Strong working knowledge of Medical Device regulations and standards (e.g., FDA, ISO 13485, MDD).
  • Experience utilizing Microsoft Office Suite
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For Illinois (IL), the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.