As a Sr. Product Development Engineer II you will design Abiomed's next generation of innovative heart pumps and accessories. You will work with clinicians to develop user needs, ideate novel concepts, rapidly prototype solutions, design & develop capable and scalable manufacturing processes. You will work in a dynamic fast paced environment that is disrupting the medical device industry by bringing breakthrough technologies to market. The ideal candidate brings deep experience in product design and manufacturing of medical devices. This role focuses on the Impella ECP or "Expandable Cardiac Power". The Impella ECP is Abiomed's smallest heart pump that does not compromise on flow by utilizing unique expanding pump technology.

Principle Duties and Responsibilities may include :

• Lead early-stage design and development projects of novel hemodynamic support devices and accessories.
• Lead initiatives with engineers in research, product development, new product introduction and contract manufacturers or OEMs. Collaborate to deliver designs with margin to performance requirements and demonstrated process capability in scalable manufacturing processes.
• Conceptualize, design, prototype, procure, and build components and assemblies for products and testing/manufacturing fixtures.
• Responsible for tolerance stack-up of critical components and assemblies ensuring the individual component tolerances are carefully considered to meet overall system performance requirements.
• Responsible for material selection based on performance requirements, manufacturing methods, duration and nature of body contact.
• Serve as Subject Matter Expert (SME) across platforms and lifecycle phases from research through sustaining teams
• Conduct voice of the customer and transform clinical observations into new device concepts and requirements
• Generate intellectual property through invention disclosures in pursuit of patients and trade secrets.
• Conduct feasibility testing, analyze, and report on test results providing conclusions and recommendations.
• Bring solutions to market by collaborating with an exceptional cross-functional team.
• Perform failure investigations in the event of test failures with support from the technical team.

Job Qualifications:

• BS in Mechanical Engineering or directly related scientific discipline.
• 8-10+ years of related experience in medical device product development
• Advanced capability using Solidworks 3D modeling, 2D drawing applying GD&T. Able to model complex parts and assemblies and conduct intermediate structural and fluid FEA within solidworks or similar packages.
• Experience in design for manufacturing of plastic molded components, extrusions, complex catheter shafts, laser-cut and precision machined metal components and ceramics
• Deep background in plastics, metal, and ceramic material selection
• Strong problem-solving skills and demonstrated experience identifying root cause of device failures.
• Demonstrated ability to execute tasks in a timely manner under minimal supervision.
• Willingness to learn the interventional cardiology space - the devices and the clinical practice.
• Experience applying statistical techniques and analysis.
• Willingness & ability to travel internationally ~5% of the time.

Strongly Preferred Qualifications :

• Experience in FDA Class II and III medical devices.
• Hands on experience in prototyping in pilot manufacturing and rapid prototyping; basic machine shop equipment
• Hands on experience in testing in a laboratory environment
• Strong understanding of design control and risk management processes and deliverables
• Strong understanding of statistical analysis of data, DOE's, DMAIC, DFSS, Six Sigma Green Belt+

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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