At Luma Therapeutics, you will have broad responsibility for medical device manufacturing engineering, ranging from component sourcing and development, into manufacturing process, tooling, and equipment development and through full scale manufacturing release, both in-house and contract manufactured.  You are a hands-on engineer with deep experience in medical device development and manufacturing, have demonstrated creative problem solving skills within the regulated field, have excellent task and time management skills, and thrive in a fast-paced environment with a range of activities from day to day.  Ideally, you have experience in an entrepreneurial / start-up environment.

The range of responsibilities include manufacturing development from prototype to full scale production, Class 1 Exempt to Class 2 (and potentially higher), disposables to capital equipment, and from polymers to electronics.

  • Manufacturing Process Development
  • Medical Device Development, Build, Test, and Launch
  • Contract Manufacturer Selection, Development, and Management
  • Supply Chain Management

Minimum Qualifications:

  • Bachelor’s Degree in Engineering:  Mechanical, Electrical, or Biomedical preferred.
  • 5+ years of medical device development and launch experience in FDA-regulated environment.
  • Deep working knowledge of and experience in Medical Device Quality Management Systems (FDA QSR, ISO 13485)
  • Broad experience in medical device manufacturing processes and techniques

Preferred Qualifications:

  • Master’s Degree in Engineering
  • 10+ years in medical device development
  • Polymer and adhesives development and manufacturing
  • Electronics development and contract manufacturing

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