Program Manager, NPI
New
W
WillowMedical Devices
Remote, USAFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 12+ years of experience, with 5+ years of program or project management in medical devices or another regulated hardware/software industry.
- Required Skills
- AgileJiraConfluenceRisk Management
Requirements
- 12+ years of experience, with 5+ years of program or project management in medical devices or another regulated hardware/software industry.
- Bachelor's degree or higher preferred, or equivalent experience.
- 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 and quality teams to meet design control requirements.
- Experience coordinating hardware, firmware, and connected software/app workstreams.
- Experience using Atlassian tools such as JIRA & Confluence.
- Strong familiarity with project management software tools like SmartSheet.
- Agile project management style, approach, and execution.
- Ability to communicate technical problems and solutions clearly.
- Project Management Professional (PMP) or Program Management Professional (PgMP) certification preferred.
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.
- Act as 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.
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