Medical Device Manufacturing Engineer

3 weeks ago


Cambridge, Massachusetts, United States KLM Careers Full time
About the Job

The Senior Manufacturing Engineer will play a critical role in fostering collaboration between R&D, Pilot, and commercial manufacturing phases to contribute from Early Human Use to the commercialization of new medical products.

This position will ensure that design and manufacturing processes are characterized, robust, scalable, and compliant with regulatory requirements while utilizing the best technologies and methodologies such as LEAN Six Sigma and Design for Manufacturing.

Responsibilities
  • Develop and optimize manufacturing processes for medical devices
  • Produce production-level assembly and part drawings
  • Identify and evaluate contract manufacturing partners
  • Liaise between Contract Manufacturing Organization (CMO) and Canon
  • Review engineering specifications and CAD data
  • Manage part/drawing release and BOM accuracy
  • Create and maintain manufacturing documentation
Requirements
  • Bachelors degree or higher in Mechanical Engineering
  • ~5+ years of experience in medical device manufacturing engineering
  • ~At least three years in new product development and production design transfer
  • Strong knowledge of cart systems, console operations, and electromechanical devices
  • Proficient in SolidWorks for modeling and drawing
  • Experience with contract manufacturers and capital equipment
  • Highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP
  • Lean and/or Six Sigma certifications are a plus
What We Offer
  • Health, dental, and vision insurance
  • Retirement savings plan with company matching
  • Generous vacation and paid time off policy
  • Flexible working hours
  • Remote work options available

Cambridge is a hub of innovation and collaboration, home to many leading universities and research institutions. The city offers a rich cultural experience, diverse dining options, and ample opportunities for professional networking and advancement, making it an ideal place for your career development.



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