Staff R&D Engineer (Process Development) - Shockwave Medical

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

R&D Product Development

Job Sub Function:

R&D Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

New Brighton, Minnesota, United States of America

Job Description:

Johnson & Johnson is hiring for a Staff R&D Engineer (Process Development) - Shockwave Medical to join our team located in New Brighton, Minnesota.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Staff R&D Engineer (Process Development) will leverage advanced technical expertise to design and optimize innovative products for treating cardiovascular diseases. As the process development subject matter expert, this role will lead early prototype creation, oversee pilot manufacturing and testing, and guide product transition from development to full-scale production. Partnering closely with R&D, operations, regulatory, and quality teams, the engineer will drive process development, validation, and implementation across multiple cross-functional projects.

Essential Job Functions

• Design and develop product(s) for manufacturing in compliance with the company's Design Control requirements and applicable regulatory requirements.

• Prototype and develop proof of concept process designs and bench models to test these concepts in a simulated environment.

• Develop, validate, and maintain test methods.

• Develop new catheter manufacturing processes based on design intent and DFM principles.

• Develop and maintain technical documentation such as drawings for equipment, fixtures, components, and assemblies for manufacturing processes.

• Performs testing, analyze results and provides recommendations for design selection.

• Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping pilot operation and design verification and validation activities.

• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.

• Participates in technical design reviews to ensure all design inputs and user needs are met.

• Supports product development teams in executing projects from concept to commercialization.

• Supports base business and/or continuous improvement projects.

• Support commercial products as subject matter expert on product design, including design changes and regulatory inquiries.

• Responsible for ensuring proper documentation consistent with company's quality system.

• Responsible for knowing and planning activities consistent the company's quality policy and quality objectives.

• Supports pilot manufacturing as well as commercial production.

• Identify and maintain relationships with suppliers to ensure the delivery of superior components and services.

• Enhance the intellectual property position of the company via invention disclosures and patent applications.

• Supports company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.

• Other duties as assigned.

Requirements

• Bachelor's Degree in Mechanical or Biomedical Engineering with 8 years' experience in medical device process development engineering or a Master's Degree in Mechanical or Biomedical Engineering and 6 years' experience in medical device process development engineering.

• Experience in developing catheters and access delivery systems from concept to commercialization

• Experience in catheter devices process development from prototype creation to full-scale production

• Experience in leading cross-functional technical teams

• Experience in representing R&D/Process Development on a cross-functional core team

• Experience with balloon expandable and/or self-expanding implants is a plus

• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.

• Experience with CAD software (i.e. Solidworks)

• Experience with statistical analysis and design of experiments (DOE).

• Experience with computational modeling (i.e. finite element analysis, computational fluid dynamics) is a plus.

• Effective communication skills, written and verbal, with all levels of management and organizations.

• Operate independently and adaptability to changing requirements.

• Ability to work in a fast-paced environment, managing multiple priorities.

• Experience developing disposable medical devices.

• Employee may be required to lift objects up to 25lbs.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Agile Decision Making, Coaching, Critical Thinking, Emerging Technologies, Engineering, Problem Solving, Process Control, Process Engineering, Process Improvements, Product Costing, Product Improvements, Research and Development, SAP Product Lifecycle Management, Situational Awareness, Technical Research, Technical Writing, Technologically Savvy, Vendor Selection

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation- 120 hours per calendar year

Sick time- 40 hours per calendar year; for employees who reside in the State of Colorado- 48 hours per calendar year; for employees who reside in the State of Washington- 56 hours per calendar year

Holiday pay, including Floating Holidays- 13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave- 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave- 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave- 80 hours in a 52-week rolling period10 days

Volunteer Leave- 32 hours per calendar year

Military Spouse Time-Off- 80 hours per calendar year