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Sr. Product Development Engineer 1

Date:  Jun 7, 2021
Location: 

Danvers, MA, US, 01923

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

 

Candidate will be responsible for complex technical efforts, design initiatives, product/process development, and problem solving as part of the vascular access product development team.  Position will have a focus developing interventional cardiology delivery and introducer systems for the Impella heart pump. Strong communication, planning, organization, and hands on skills required. 

 

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:

  • 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.


Nearest Major Market: Boston