Abiomed is recruiting for a Product Development Engineer II based in Danvers, MA. The ideal candidate will be goal & data-driven, detail oriented, and experienced in the medical device industry. Ideally, this new team member will come in with experience in the technical development of class III medical devices for chronic application, bringing new products to market through commercial launches and/or first in human studies. This position will lead complex technical design and development tasked activities, collaborate with senior and junior staff to execute tasks, and coordinate with cross-functional teams to achieve success.
Responsibilities:
- Use technical expertise, knowledge, and experience to rapidly innovate the companies’ medical devices for use in chronic heart failure patients.
- Lead analyses in mechanical, fluid, vibration, thermal, reliability, magnetic and systems evaluation to support new and existing designs; leveraging strong collaboration with subject matter experts is required.
- Perform literature reviews, engage with physician, and heart failure care professionals, and develop quantitative analyses to unique problem sets spanning materials science, systems thinking, mechanical design, and biomechanical dynamics.
- Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include design for manufacturing, assembly, and automation.
- Rapidly build prototypes by using internal machine shop, engineering production line tooling and equipment, and/or external resources.
- Test, and analyze engineering prototypes using statistical analysis in Minitab and apply to the design effort (Multivar chart, t-tests, confidence/reliably analysis, Gauge R&R) to iterate concepts toward extremely innovative yet robust solutions.
- Develop and prepare test protocols, reports, and engineering summaries with expertise in technical writing capabilities.
- Perform process development studies in collaboration with MFG teammates and bring an open mind to design solutions which enable manufacturability internally and at external suppliers.
- Generate 3D CAD models and engineering drawings in Solid works using GD&T with ability to write specifications and to perform tolerance stack-up analyses.
- Prepare and deliver PPT presentations of technical design reviews to cross-functional team members.
Qualifications
Requirements:
- 3 years product development experience; strong preference for experience with class III medical device development
- BS in Mechanical or Biomedical Engineering required; advanced degree in related discipline preferred.
- Ability to travel up to 20% of the time, domestically & international (US & EU)
- Experience spending time in clinical environment preferred (i.e. OR, ICU, engaging with heart failure and/or cardiac physicians).
- Ability to work in cross-functional teams that span global operations. Proficient in English verbal and written communication.
- Must enjoy team approach over individual contributions.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
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