SENIOR PRODUCT DEVELOPMENT ENGINEER

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.
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  Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Sr.
Product Development Engineer located in Danvers, MA.
The preCARDIA engineering team is working to develop technologies for early feasibility studies for a novel treatment for heart failure patients.
The ideal candidate for the Sr.
Product Development Engineer I role will have experience in the medical device industry and be adaptable and enthusiastic about collaborating as part of a cross-functional team to drive development across all stages of product development from conceptualization through product launch.
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.
Principle Duties and Responsibilities.
Provide product development expertise leading design and development initiatives of novel introducer sheaths, delivery systems, and accessories from conception to commercialization Establish design goals and specifications based on requirements and user needs Coordinate and participate in technical efforts amongst test engineers, process engineers, technical writers, and technicians in the execution of project deliverables (testing, root cause investigations, etc.) Fabricate prototypes with assistance from Junior and Principal staff and technical support team (machine shop and designers).
Coordinate with outside vendors and contract manufacturers who are performing design services or process development in the prototyping and development phases.
Lead technical design and project phase reviews.
Support the generation of risk documentation including dFMEA, uFMEA, pFMEA, hazard analysis, and risk management plans/reports.
Interface with the commercial team and clinicians in support of voice of the customer, customer outreach, and product evaluation activities.
Participate as part of cross-functional project teams including quality engineering, regulatory, supplier engineering, project management, manufacturing  Qualifications Qualifications.
BS in Mechanical, Biomedical Engineering or directly related scientific discipline 5 years of medical device engineering or product development experience Experience in leading medical device development projects and execution of design controls to ISO.
Knowledge of clinical use in endovascular/interventional cardiology/cardiac surgery and cath lab preferred.
Strong problem solving skills and experience identifying root cause of device failures.
Ability to communicate ideas and information clearly, ability to motivate and empower team members.
3D modeling and 2D drawing experience required.
Solidworks preferred.
Experience in the design of polymer components and assemblies preferred.
Experience with processing of plastics including thermoforming, adhesive bonding, injection molding,extrusion, assembly, and ultrasonic and RF welding preferred.
Experience applying statistical techniques and analysis.
May require up to 10% travel – US & EU   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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