PD Program Manager

Job description

Position Description: PD Program Manager for Medtronic, Inc. Lead released product management (RPM)/sustainment programs (25%). Provide Technical and Engineering insights on energy-based products to assess impact of changes on overall function and performance of devices (15%). Evaluate design and process impacts for changes incorporated as a part of remediation effort addressing field complaints and supplier component changes (10%). Coordinate Voice of Customer (VOC) activities and formative and summative studies (10%). Ensure compliance by navigating and adhering to government and industry regulations including FDA QSR 21 CFR 820, ISO 13485 (Medical Device), ISO 10993 (Biocompatibility), IEC 62366 (Usability Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software Development Life Cycle) (10%). Responsible for executing projects and ensuring effective collaboration with team members across different time zones and cultural environments (2%). Utilize Monte Carlo simulations to assess and quantify risks and uncertainties across all phases of the project lifecycle, including design, development, testing, regulatory approval, and production (3%). Con...