Lead NPI Program Manager, Connected Medical Devices

Willow Innovations, Inc.

United States

On-site

USD 140,000 - 190,000

Full time

4 days ago

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Job summary

Willow Innovations, Inc. 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. You will drive requirements gathering, design controls, and technical feasibility, and execute cross-functional plans to hit milestones from concept through launch and

Qualifications

12+ years of experience in program management.
5+ years of PM in medical devices or regulated hardware/software.
Experience leading NPI programs for connected medical devices.
Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, ISO 14971.
Bachelor's degree or higher preferred.

Responsibilities

Manage complex cross-functional NPI programs for connected medical devices from concept through design, verification/validation, transfer to manufacturing, and sustaining.
Collaborate with hardware, firmware, software, regulatory/quality, clinical, and manufacturing teams to define requirements, priorities, scope, budget, and timelines.
Manage risk per ISO 14971 by identifying, assessing, and mitigating regulatory and schedule risks across the lifecycle.
Own program schedules, DHF milestones, and phase-gate deliverables with quality and regulatory teams.
Coordinate device connectivity workstreams (Bluetooth/BLE, companion app, cloud/data integration) with software/security teams for a cohesive UX.