Program Manager, NPI

Willow-Innovations; Mountain View (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Willow Innovations in Mountain View, CA, seeks an experienced Program Manager to lead NPI for connected medical devices, coordinating hardware, firmware, software, regulatory, quality, clinical, and manufacturing teams from concept to launch.

The role demands 12+ years in regulated hardware/software, FDA QSR, ISO 13485, and strong cross-functional leadership with Jira/Confluence; PMP or PgMP is preferred.

Qualifications

• 12+ years of experience in 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.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, and ISO 14971; experience partnering with regulatory/quality teams.

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 milestones, and phase-gate deliverables in partnership with quality and regulatory affairs.
• Coordinate device connectivity workstreams (Bluetooth/BLE, companion app, cloud/data integration) with software and security teams to ensure 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.

Skills

Program Management

NPI

Regulatory Knowledge

Cross-functional Leadership

FDA QSR

ISO 13485

JIRA

Confluence

Risk Management

Agile

Education

Bachelor's degree or higher

Tools

JIRA

Confluence

SmartSheet

Job 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.
• 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Willow Innovations’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.