Program Manager, NPI
Lead new product introduction for connected medical devices in a mission-driven remote team.
Posted by employer 2 days ago
First seen on Joblaze 1 day ago
Last verified on the company career page 1 day ago
Skills & Technologies
What you'll build
- Manage complex cross-functional NPI programs
- Collaborate with hardware, firmware, and software teams
- Drive program-level risk management
- Own and maintain program schedules
- Coordinate device connectivity workstreams
Must have
- 12+ years of experience
- 5+ years of program or project management in medical devices
- Experience leading NPI programs for connected medical devices
- Working knowledge of FDA QSR and ISO standards
- Experience coordinating hardware, firmware, and software workstreams
Nice to have
- Bachelor's degree or higher preferred
- Experience using Atlassian tools
- Project Management Professional (PMP) certification preferred
Requirements
- Experience
- 12+ years
- Education
- Bachelor's degree
Not disclosed in this posting: compensation, visa sponsorship.
Joblaze summary
The Program Manager for New Product Introduction at Willow oversees the development of connected medical devices, managing complex projects from initial concept through to market launch and ongoing support. This role demands expertise in coordinating cross-functional teams, including hardware, software, and regulatory affairs, while ensuring compliance with industry standards. Ideal candidates will have over a decade of experience in program management within regulated environments, particularly in medical devices, and possess strong communication skills to navigate technical challenges. Willow's mission-driven approach emphasizes collaboration and innovation in improving women's health.
Joblaze insights
- Listed yesterday on Joblaze — tracked directly from Willow's career page.
- Willow has 4 other open roles including Project Manager, Consumer Products – Maternal Care, Sr Director of Engineering (EE, Firmware, Software & Cloud), Sr. Global Demand Planning Manager.
- 304 active Jira roles on Joblaze right now.
- 91 active Confluence roles on Joblaze right now.
- 33 active SmartSheet roles on Joblaze right now.
- Typical Jira salary we track runs $92,459–$156,000 (median $119,040, across 156 roles). See Jira salary trends
Quick facts
- Is the Program Manager, NPI role remote?
- Yes — Willow lists this as a fully remote position.
- How much experience is required?
- At least 12 years of relevant experience for this Program Manager, NPI role.
- What's the tech stack?
- Joblaze extracted these technologies from the posting: Confluence, FDA QSR, IEC 62304, ISO 13485, ISO 14971, Jira.
- What seniority level is this role?
- Willow targets senior candidates for this position.
- Is this full-time or contract?
- Full-time for this Program Manager, NPI role at Willow.
From the original posting
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.
- 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.
- An ability to communicate technical problems and solutions clearly to diverse audiences at all levels of the organization.
- A strong sense of ownership, urgency, and drive.
- An agile project management style, approach, and execution.
- Strong familiarity with project management software tools (e.g. SmartSheet, JIRA/Atlassian), methodologies, and best practices.
- Project Management Professional (PMP) or Program Management Professional (PgMP) certification preferred.
Willow is proud to be an equal opportunity workplace. We are committed to equal employment opportunities regardless of gender, race, religion, sexual orientation, gender identity, age, marital status, disability, or Veteran status.