Leads cross-functional new product introduction programs for connected medical devices from concept through launch and sustaining. Coordinates hardware, firmware, software, regulatory, quality, clinical, and manufacturing teams; manages requirements, schedules, budgets, risks, design controls, DHF milestones, phase gates, connectivity workstreams, design transfer, and manufacturing readiness. Communicates program status and recommendations to leadership while removing obstacles and driving stakeholder alignment.
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.
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.
- 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.
Similar Jobs
Artificial Intelligence • Cloud • Information Technology • Consulting
Leads global, cross-functional New Product Introduction programs for commodity SKUs and product platform launches. Responsibilities include managing schedules, budgets, resources, deliverables, risks, escalations, and stakeholder communications. Coordinates engineering, manufacturing, supply chain, and external partners to ensure products launch on time and within budget. The role also drives process improvements, resolves complex issues, and mentors less-experienced team members.
Top Skills:
Ai Tools And TechnologiesProject Planning SoftwareSemiconductor Technology
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Leads Takeda’s global PAT technology and innovation strategy across manufacturing. Owns the multi-year roadmap, innovation portfolio, technology standards, vendor partnerships, and deployment of analytical technologies, process models, automation, digital twins, and AI-enabled manufacturing solutions. Drives PAT industrialization from scouting through validated GMP implementation, including RTRT and advanced process control. Establishes data integrity, validation, regulatory, and lifecycle governance while delivering improvements in quality, yield, productivity, release time, and supply reliability. Develops organizational capability and coordinates cross-functional stakeholders across MSAT, manufacturing, quality, engineering, and digital technology.
Top Skills:
Advanced Process Control (Apc)Artificial IntelligenceChemometricsComputerized System ValidationData PlatformsDigital TwinsGamp 5Mass SpectrometryModel Predictive ControlMultivariate Data AnalysisNir SpectroscopyProcess Analytical Technology (Pat)Process AutomationProcess ModelingQbdRaman SpectroscopyReal-Time Release Testing (Rtrt)Soft SensorsUv Spectroscopy
Automotive • Professional Services • Software • Consulting • Energy • Chemical • Renewable Energy
Drives sales of UL products and services across assigned TIC accounts, managing prospecting, discovery, proposals, closing, renewals, and pipeline development. Builds customer relationships using technical credibility, collaborates with engineers and sales teams on specialized opportunities, supports account planning, and transitions closed deals to fulfillment teams. Works with account managers to identify growth opportunities and meet or exceed sales targets.
Top Skills:
Crm SoftwareExcelMicrosoft OutlookMicrosoft PowerpointMicrosoft Word
What you need to know about the NYC Tech Scene
As the undisputed financial capital of the world, New York City is an epicenter of startup funding activity. The city has a thriving fintech scene and is a major player in verticals ranging from AI to biotech, cybersecurity and digital media. It also has universities like NYU, Columbia and Cornell Tech attracting students and researchers from across the globe, providing the ecosystem with a constant influx of world-class talent. And its East Coast location and three international airports make it a perfect spot for European companies establishing a foothold in the United States.
Key Facts About NYC Tech
- Number of Tech Workers: 549,200; 6% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Capgemini, Bloomberg, IBM, Spotify
- Key Industries: Artificial intelligence, Fintech
- Funding Landscape: $25.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Greycroft, Thrive Capital, Union Square Ventures, FirstMark Capital, Tiger Global Management, Tribeca Venture Partners, Insight Partners, Two Sigma Ventures
- Research Centers and Universities: Columbia University, New York University, Fordham University, CUNY, AI Now Institute, Flatiron Institute, C.N. Yang Institute for Theoretical Physics, NASA Space Radiation Laboratory
