Product Development Engineer II, Surgery

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.