Marie Fazio Miller

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

Certifications

• Project Management Professional (PMP)