Senior Project Manager

Senior Project Manager – Medical Device Development Minnesota | On-Site | Permanent We are partnering with a medical device CDMO to find a Senior Project Manager to own complex new product development programs from concept through commercialization. Current programs are in or approaching design verification across catheter systems, delivery platforms, and energy delivery consoles. This is a high-ownership role. The PM is the voice of the customer internally and the face of the company externally — managing the relationship, driving the program, and resolving problems before they become crises. There is no junior support and no extended ramp. The right person steps in and leads. What You Will Be Doing Leading 1-3 concurrent development programs with full accountability for timeline, budget, risk, and customer relationship. You will set priorities for cross‑functional teams spanning R&D, electrical, software, quality, and operations, while ensuring programs stay compliant with FDA regulations and internal quality system requirements. You will also contribute to a PMO framework currently being built out across the organization. What We Are Looking For Minimum 7 years of combined experience — 3-5 years of hands‑on engineering work in manufacturing, R&D, quality, process development, or electrical, followed by 2-4 years in a project management capacity Medical device development experience is required; candidates must understand how FDA regulations shape the development process Demonstrated ability to own programs end‑to‑end and interface directly with customers in a project ownership role Strong communicator who can align stakeholders at all levels without formal authority What Sets a Candidate Apart Prior CDMO experience is a meaningful differentiator Familiarity with 510(k) submission processes and regulatory milestones PMP is not required and will not be weighted heavily — engineering depth and practical PM experience matter far more #J-18808-Ljbffr