Medical Device Senior 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
  • Incorporate DFM, Six Sigma, and LEAN principles into designs
  • 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
  • Execute experiments and tests on product lines
  • Conduct Characterization and Validation activities
  • Create and maintain manufacturing documentation
  • Coordinate technical communications
Requirements
  • Bachelor's degree in Mechanical Engineering or a related field
  • Minimum of 5 years in medical device manufacturing
  • Experience in managing and improving cart/console systems
  • Familiarity with sterilizable polymers and catheter fabrication techniques
Why Work in Cambridge, MA

Cambridge is a hub of innovation and collaboration, home to many leading universities and research institutions. The vibrant atmosphere fosters creativity and growth, with a strong focus on technology and health care. 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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