Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Product Development Engineer located in Danvers, MA.
Principal Duties & Responsibilities :
· Support design & development projects of novel hemodynamic support devices and accessories from concept through development, verification & validation, and transfer to manufacturing.
· Support technical efforts amongst senior engineers, test engineers, designers, technical writers, and technicians in the execution of project deliverables.
· Conceptualize, design, procure, and build components and assemblies for products and testing/manufacturing fixtures.
· Support the planning and execution of animal and cadaver labs throughout the development cycle.
· Conduct feasibility/verification testing, analyze, and report on test results providing conclusions and recommendations. Perform failure investigations in the event of test failures with support from the technical team.
· Lead subproject technical initiatives at contract manufacturers or OEMs. Coordinate vendor deliverables, track progress, and communicate status to project team.
· Draft design control deliverables including design inputs/outputs and verification/validation efforts with the support of senior engineers.
· Support the generation of risk documentation including dFMEA, uFMEA, pFMEA, hazard analysis, and risk management plans/report with the support of senior engineers.
· Author test plans, protocols, and summary reports following completion of formal testing.
· Comply with documentation requirements of design control defined by ISO 13485.
· BS in Mechanical, Biomedical Engineering or directly related scientific discipline.
· 2+ years of medical device engineering or product development experience
· 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 in industry or education.
· Willingness & ability to travel internationally ~5% of the time.
Strongly Preferred Qualifications :
· 2 years of medical device engineering or product development experience preferred.
· Manufacturing/Prototyping and hands-on experience preferred.
· 3D modeling and 2D drawing experience preferred.
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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