Reliability Engineer II

Job Title: Reliability Engineer II Job ID:24117 Location: Mounds View Minnesota 55112 Duration: 12 Months Payrate: $45.00- $50.00/HR. on W2 JOB DESCRIPTION Can you please confirm your top 3 skills sets required? Reliability Engineering, Test Method Development, Test Method Validation Can you please confirm the 3 main responsibilities/day to day activities required for this role? Setup and execution of test methods for Test Method Validation or Design Verification, Report writing and approval, Review of design, manufacturing and supplier change orders. What products (if any) will this role support? Affera Disposable products: Sphere-9, Tubing Set, and Extension Cable What is your target years of experience? 2-4 years When do you plan to start interviewing? March Will you be looking to hire and start ASAP or will the start date be delayed? ASAP Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? OnsiteTECHNICAL SKILLS Must Have Bachelor's Degree in Engineering, Science or technical field with 1+ years of work experience in Engineering and/or Quality Experience in Reliability Testing, Design Verification, Test Method Validation and strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team Nice To Have 1+ years of Medical Device industry experience, Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR) Familiar with these standards: ISO 13485, ISO 14971, IEC 60601, Knowledge of Client Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS. Responsibilities may include the following and other duties may be assigned. Perform reliability activities (design verification, reliability testing, test method validation, etc.). Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new or existing design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 1+ years of relevant experience.