Sr Product Development Engineer

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

Abiomed is a fast-paced medical device company with a portfolio of percutaneous heart pumps that improve and save the lives of patients around the world. As the Sr. Product Development Engineer, you will make significant contributions to innovative technolgoies that facilitate the Impella heart pump's insertion ito the patient's vasculature and heart. The role is responsible for key engineering project deliverables while managing project scope, budget, and timeline. The Sr. Engineer is responsible for reviewing and reporting on the overall program and making technical decisions with support staff. Understanding the technical activities within the project, early identification of risks and their mitigations, and maintaining critical path are key criteria for the position.

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 engineering, new product introduction, clinical, and product management.

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 ISO13485.
• 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

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.