Medical Device Senior Manufacturing Engineer

4 days ago

Cambridge, Massachusetts, United States KLM Careers Full time
Job Overview

The Senior Manufacturing Engineer will play a pivotal role in driving collaboration between R&D, Pilot, and commercial manufacturing phases to contribute 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 best-in-class technologies and methodologies such as LEAN Six Sigma and Design for Manufacturing.

Key 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
  • 5+ years of experience in medical device manufacturing engineering
  • At least three years in new product development and production design transfer
  • Proven track record in design transfer and process validation
  • Experience in troubleshooting and optimizing electromechanical systems
  • Strong modeling skills in SolidWorks

Why KLM Careers?

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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