NPI Program Manager, Connected Medical Devices

Femtech Insider Ltd.; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Willow seeks an experienced Program Manager to lead NPI for connected medical devices. You will collaborate with hardware, firmware, software, regulatory, quality, and clinical teams to ensure safe, reliable products from concept through launch and sustaining.

Requirements include 12+ years in PM for medical devices or regulated hardware/software, with 5+ years in NPI. Knowledge of FDA QSR, ISO 13485, and IEC 62304 is essential. Proficiency with Jira/Confluence and SmartSheet is expected.

Qualifications

• 12+ years of experience, with 5+ years of program or project management in medical devices or regulated hardware/software.
• Bachelor’s degree or higher preferred, or equivalent experience.
• Experience leading 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, ISO 14971; partner with regulatory/quality teams.
• Experience coordinating hardware, firmware, and connected software/app workstreams within a single program.
• Experience using Atlassian tools such as JIRA & Confluence for PM, analysis, and reporting.
• Strong communication of technical problems to diverse audiences; ownership and urgency.

Responsibilities

• Manage complex cross-functional NPI programs from concept to launch and sustaining.
• Collaborate with hardware, firmware, software, regulatory, quality, and clinical teams to define requirements and timelines.
• Drive program-level risk management per ISO 14971; identify and mitigate risks.
• Own and maintain program schedules, DHF milestones, and phase-gate deliverables.
• Support design transfer and manufacturing readiness with operations and contract manufacturers.
• Coordinate device connectivity workstreams (Bluetooth/BLE, app, cloud) with software/security teams.
• Develop recommendations and communicate status and risks to leadership.
• Be a force-multiplier to resolve issues and remove obstacles across teams.

Skills

NPI program management

Regulatory knowledge

Cross-functional leadership

Hardware/firmware/software integration

Communication to diverse audiences

Agile project management

Project management tools familiarity

Education

Bachelor’s degree or higher preferred

PMP or PgMP certification preferred

Tools

JIRA

Confluence

SmartSheet

Job description

Willow seeks an experienced Program Manager to lead NPI for connected medical devices. You will collaborate with hardware, firmware, software, regulatory, quality, and clinical teams to ensure safe, reliable products from concept through launch and sustaining.

Requirements include 12+ years in PM for medical devices or regulated hardware/software, with 5+ years in NPI. Knowledge of FDA QSR, ISO 13485, and IEC 62304 is essential. Proficiency with Jira/Confluence and SmartSheet is expected.