NPI Leader for Connected Medical Devices

Willow-Innovations; Mountain View (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Willow Innovations in Mountain View, CA, seeks an experienced Program Manager to lead NPI for connected medical devices, coordinating hardware, firmware, software, regulatory, quality, clinical, and manufacturing teams from concept to launch.

The role demands 12+ years in regulated hardware/software, FDA QSR, ISO 13485, and strong cross-functional leadership with Jira/Confluence; PMP or PgMP is preferred.

Qualifications

• 12+ years of experience in program or project management in medical devices or another regulated hardware/software industry.
• Experience leading NPI programs for connected or electro-mechanical medical devices through the full lifecycle.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, and ISO 14971; experience partnering with regulatory/quality teams.

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 milestones, and phase-gate deliverables in partnership with quality and regulatory affairs.
• Coordinate device connectivity workstreams (Bluetooth/BLE, companion app, cloud/data integration) with software and security teams to ensure 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.

Skills

Program Management

NPI

Regulatory Knowledge

Cross-functional Leadership

FDA QSR

ISO 13485

JIRA

Confluence

Risk Management

Agile

Education

Bachelor's degree or higher

Tools

JIRA

Confluence

SmartSheet

Job description

Willow Innovations in Mountain View, CA, seeks an experienced Program Manager to lead NPI for connected medical devices, coordinating hardware, firmware, software, regulatory, quality, clinical, and manufacturing teams from concept to launch.

The role demands 12+ years in regulated hardware/software, FDA QSR, ISO 13485, and strong cross-functional leadership with Jira/Confluence; PMP or PgMP is preferred.