• Manage medical device programs end-to-end from concept through commercialization, ensuring deliverables are met on time, risks are anticipated and mitigated, and stakeholders are kept informed. • Own integrated project plans, timelines, budgets, and risk management activities across all program phases. • Coordinate cross-functional teams to ensure alignment on timelines, resource requirements, dependencies, and critical path activities throughout the device development lifecycle. • Track critical path activities across engineering, regulatory, clinical, and commercial workstreams, proactively identifying risks or delays and driving resolution. • Show agility by adapting programs as they develop and change in order to meet the technical, regulatory, and commercial challenges inherent in medical device innovation. • Drive continuous improvement efforts by recommending enhancements to device development processes, design control systems, and cross-functional collaboration. • Lead cross-functional development programs for Class II medical devices from concept through FDA 510(k) clearance and commercialization. • Drive execution across R&D, Quality, Regulatory, Manufacturing, Clinical, and Supply Chain teams. • Partner closely with Regulatory Affairs to support 510(k) strategy, submission development, and FDA interactions. • Work with R&D to plan, track, and coordinate required testing and validation activities, including biocompatibility testing (ISO 10993), sterilization validation, packaging validation, and shelf life and aging studies. • Work with Design Assurance to track design milestones including design inputs/outputs, verification, validation, and design reviews. • Support design transfer activities, manufacturing readiness assessments, process validations, and supplier qualifications for medical device production. • Support vendor and contract manufacturer partnerships related to device development, testing, sterilization, packaging, and production. • Schedule and lead cross-functional meetings, design reviews, risk management sessions, and milestone reviews, maintaining organized documentation and meeting summaries. • Develop high-quality documentation and presentations that clearly communicate complex technical and regulatory information, demonstrate strategic insight, and convey a confident executive presence when engaging with senior leadership. • Provide clear and concise project status updates to leadership and stakeholders. • Partner with R&D, Engineering, Quality, Regulatory Affairs, Clinical, Supply Chain, and Commercial teams to drive device development, verification and validation, regulatory submissions, and launch readiness.