Marie Fazio Miller

Project Manager, Medical Device Development

Professional Experience
Project Management Professional (PMP) with 15 years experience in medical device industry. Experienced in hardware and software design controls, development, verification/validation, risk management, manufacturing process development, and regulatory submission (de novo, 510(k), CE Mark). Versed in ISO 13485, ISO 14971, ISO 62304, and FDA guidance and requirements. Led cross-functional teams to develop products for clients such as Abbott and LabCorp.

  • Project Manager, Medical Device Development, Innovenn
  • Director of Operations, GenPrime
  • Project Manager, Medical Device Development, GenPrime
  • Research & Quality Control Technician, GenPrime


  • Project Management Professional (PMP)


Bachelor of Science in Biology with a concentration in Entrepreneurial Leadership from Gonzaga University