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Senior Biomedical Engineer

Parsippany, New Jersey
Growing Medical Device company in Parsippany, NJ

 Senior Biomedical Engineer (New Product Development)                                

Job Description:
Job Summary:
The Senior Biomedical Engineer is part of the R&D team working on development efforts associated with the companies product lines. The engineer will work with cross-functional team members in R&D, regulatory, quality and manufacturing on the design, development, and enhancement of new and currently marketed medical devices (e.g. defibrillators, patient monitors, ventilators). Primary responsibilities include requirements development, risk management, usability evaluation and verification/validation activities.

Essential Functions:
  • Design and development activities related to new products, product line extensions, and manufacturing support
  • Ensuring that the product architecture meets system level requirements and product lifecycle plans
  • Qualification and troubleshooting of designs
  • Risk management activities like hazard analysis
  • Supporting usability evaluation
  • Documentation associated with engineering activities - requirements, investigation summaries, feasibility reports, V&V plans and reports
  • Supports project teams and quality assurance in resolution of field issues

Skills Requirements:
  • Ability to contribute in translating high level product requirements into system and sub-system level specifications and designs
  • Knowledge and experience with one or more programming languages such as C, Python, or MATLAB
  • Experience developing products under FDA and European Community medical device regulations and standards
  • Experience with and sensitivity to human factors issues associated with the use of medical devices
  • Excellent written, verbal, and interpersonal skills
  • Positive attitude and affinity for teamwork, logic, innovation, initiative and self-sufficiency
  • Ability to handle confidential information with discretion and skill

Required/Preferred Education and Experience:
  • BS degree in Biomedical/Electrical Engineering or related discipline and 6+ years of industry experience
  • Advanced degree in Biomedical/Electrical Engineering or related discipline preferred
  • Past experience with ventilators or aspirators a plus, but not required

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