Program Manager, NPI
Willow Innovations is hiring a Program Manager to lead new product introduction (NPI) for its connected women's health medical devices (e.g., the Willow wearable breast pump). Day to day they run cross-functional programs across hardware, firmware, app, regulatory/quality, and manufacturing, owning schedules, ISO 14971 risk management, and phase-gate deliverables from concept through launch and su
- Compensation
- Not disclosed
- Location
- Remote, USA
- Work setup
- Remote
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 5+ years
- Category
- Project management
- Posted
Skills
Must have
- 12+ years of experience, with 5+ years of 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, from concept to launch and sustaining
- Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, and ISO 14971, with experience partnering with regulatory/quality teams on design controls
- Experience coordinating hardware, firmware, and connected software/app workstreams within a single program
- Experience using Atlassian tools such as JIRA & Confluence for project management, analysis, and reporting
- Ability to communicate technical problems and solutions clearly to diverse audiences at all levels
- Strong sense of ownership, urgency, and drive
- Agile project management style, approach, and execution
- Strong familiarity with project management software tools (e.g. SmartSheet, JIRA/Atlassian), methodologies, and best practices
Nice to have
- Bachelor's degree or higher, or equivalent experience
- Project Management Professional (PMP) or Program Management Professional (PgMP) certification
Full description
Willow is a platform for products that help improve the lives and health of women. We are a mission-driven team of experienced inventors, mothers, and fathers dedicated to making a difference in women’s lives. The Willow™ Wearable Breast Pump, selected as one of TIME's 25 Best Inventions in 2017 and 2018 CES Innovation Award for Wearable Technologies, is the first solution in our platform.
Job Overview:
Willow is seeking an experienced Program Manager to lead new product introduction (NPI) for our 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. The Program Manager will drive requirements gathering, design controls, and technical feasibility, and will execute cross-functional plans to hit key program milestones from concept through launch and sustaining.
What you'll do:
- 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.
- Be 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.
What you'll bring:
- 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, from concept to launch and sustaining.
- Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, and ISO 14971, and experience partnering with regulatory/quality teams to meet design control requirements.