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Willow is seeking an experienced Program Manager to lead new product introduction (NPI) for connected medical devices. This role requires close collaboration with hardware, firmware, software, regulatory/quality, clinical, and manufacturing teams to bring safe, reliable, and connected products to market.
Key responsibilities include managing complex cross-functional NPI programs from concept through design, verification and validation, transfer to manufacturing, and sustaining operations. You will collaborate with hardware, firmware, mobile/app, regulatory, quality, and clinical teams to define requirements, set priorities, and establish scope, budget, and timelines. You'll drive program-level risk management per ISO 14971 by identifying, assessing, and mitigating technical, regulatory, and schedule risks throughout the product lifecycle.
You will own and maintain program schedules, design history file (DHF) milestones, and phase-gate deliverables in partnership with quality and regulatory affairs. Acting as a force-multiplier for functional leads, you'll resolve issues, proactively remove obstacles, and facilitate cross-team decision making. You'll coordinate device connectivity workstreams (Bluetooth/BLE, companion app, cloud/data integration) with software and security teams to ensure cohesive user experience.
Additionally, you'll develop recommendations, gain stakeholder alignment, and communicate program status and risks clearly to leadership. You'll support design transfer and manufacturing readiness activities in collaboration with operations and contract manufacturers.
Required qualifications: 12+ years of experience with 5+ years in program or project management in medical devices or regulated hardware/software industries. Bachelor's degree or equivalent preferred. You must have led NPI programs for connected or electro-mechanical medical devices through full lifecycle. Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, and ISO 14971 is essential, with experience partnering with regulatory/quality teams on design controls. Experience coordinating hardware, firmware, and connected software/app workstreams is required. Proficiency with Atlassian tools (JIRA, Confluence) and other project management software (SmartSheet) is expected. PMP or PgMP certification preferred.
