Program Manager, NPI

Responsibilities

• Manage complex cross-functional NPI programs for connected medical devices, from concept through design, verification and validation, transfer to manufacturing, and sustaining.
• Collaborate with hardware, firmware, mobile/app, regulatory, quality, and clinical teams to define requirements, set priorities, and establish scope, budget, and timelines.
• Drive program-level risk management (per ISO 14971) by identifying, assessing, and mitigating technical, regulatory, and schedule risks throughout the product lifecycle.
• Own and maintain program schedules, design history file (DHF) milestones, and phase-gate deliverables in partnership with quality and regulatory affairs.
• Be a force-multiplier for functional leads to resolve issues, proactively removing obstacles and facilitating cross-team decision making.
• Coordinate device connectivity workstreams (e.g., Bluetooth/BLE, companion app, cloud/data integration) with software and security teams to ensure a cohesive user experience.
• Develop recommendations, gain stakeholder alignment, and communicate program status and risks clearly to leadership.
• Support design transfer and manufacturing readiness activities in collaboration with operations and contract manufacturers.

Languages