Location: Remote to hybrid (U.S.); Boston area strongly preferred
Experience Level: 7 12+ years
Industry: Medical Devices Class III Long-Term Implantable Devices / Drug Delivery
Degree Requirements: Bachelor s degree in Engineering or related technical discipline required; advanced degree preferred

About the Role and Job Summary

We are seeking an experienced Project Manager (Consultant) to support the development, testing, and Premarket Approval (PMA) submission of a Class III long-term implantable medical device within the Implantable Device Unit (IDU). This role will provide end-to-end project leadership across design, verification and validation, manufacturing readiness, and regulatory submission activities. The Project Manager will partner closely with Device Development, Regulatory Affairs, Quality, Manufacturing, and external partners to ensure execution remains aligned with FDA expectations, design control requirements, and program timeline...