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Our smaller bioelectronic medical device client is adding a Product Development Engineer to the team. The Product Development Engineer will manage projects  (3-5 at a time) and create fixtures for assembly.  Will also be responsible for the development and implementation of new products, developed jointly with Manufacturing Engineering, into full production, as well as supporting of continuation engineering on existing product lines. Will be collaborating with 4 Engineers and a Technician.

Your role with the company:

Product Concept

– Basic understanding of user and patient needs

– Proposes concepts to address customer needs

– Selects and documents concepts to proceed to development and commercialization

– Generates intellectual property

Design & Development

– Translates customer requirements into engineering specifications.

– Plans and manages creation of models to simulate and analyze device function.

– Plans and manages development of test fixtures and methods.

– Analyzes and optimizes design concepts through experimentation and other simulation.

– Conducts risk assessment (e.g. FMEA) of product concepts.

– Conducts feasibility studies and documents results and recommendations in technical reports. 

Verification & Validation

– Completes engineering documentation (e.g. Product & component specifications, BOMs, etc.) in readiness for design verification and validation.

– Writes design verification and validation protocols and reports

– Coordinates verification and validation builds.

– Collaborates with other functions to execute project deliverables

Desired Profile:

  • Bachelors’ degree in mechanical, electrical, bio-medical engineering or similar field of study or equivalent experience.
  • 3+ years engineering experience in the medical device industry, experience with biosensors, patient monitoring, or microelectronics a plus.
  • Experience creating fixtures using SolidWorks for assembly
  • Experience managing projects and interacting with customers.
  • Working knowledge of design controls and Quality System Regulations.
  • Self-initiator in relation to project and/or project teams.
  • Ability to coach/mentor people in junior positions is a plus.
  • Ability to determine best approach to influence without authority.
  • Ability to function in ambiguity.
  • Interest and curiosity in differing points of view.
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