Senior NPI Program Manager – Connected Medical Devices

willowinnovations; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Willow is seeking an experienced Program Manager to lead cross-functional NPI programs for connected medical devices in the United States. You will drive concept through design, verification, transfer to manufacturing, and sustaining activities, coordinating with hardware, firmware, regulatory, quality, and clinical teams.

The role requires 12+ years of program management, 5+ years in regulated hardware/software, and strong knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971.

Qualifications

• 12+ years of experience in program/project management for medical devices or regulated hardware/software.
• Bachelor’s degree or higher preferred, or equivalent experience.
• Experience leading NPI programs for connected/electro-mechanical medical devices through full lifecycle.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, ISO 14971; partnered with regulatory/quality teams.

Responsibilities

• Manage cross-functional NPI programs from concept through design, verification and validation, transfer to manufacturing, and sustaining.
• Coordinate with hardware, firmware, mobile/app, regulatory, quality, and clinical teams to define requirements and timelines.
• Drive program risk management per ISO 14971 and communicate status and risks to leadership.
• Own schedules, DHF milestones, and phase-gate deliverables in partnership with quality/regulatory teams.
• Support design transfer and manufacturing readiness with operations and contract manufacturers.

Skills

Program management

Cross-functional leadership

Communication

Ownership

Education

Bachelor’s degree or higher

Tools

JIRA

Confluence

SmartSheet

Job description

Willow is seeking an experienced Program Manager to lead cross-functional NPI programs for connected medical devices in the United States. You will drive concept through design, verification, transfer to manufacturing, and sustaining activities, coordinating with hardware, firmware, regulatory, quality, and clinical teams.

The role requires 12+ years of program management, 5+ years in regulated hardware/software, and strong knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971.