Program Manager, NPI

willowinnovations; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Willow is seeking an experienced Program Manager to lead cross-functional NPI programs for connected medical devices in the United States. You will drive concept through design, verification, transfer to manufacturing, and sustaining activities, coordinating with hardware, firmware, regulatory, quality, and clinical teams.

The role requires 12+ years of program management, 5+ years in regulated hardware/software, and strong knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971.

Qualifications

• 12+ years of experience in program/project management for medical devices or regulated hardware/software.
• Bachelor’s degree or higher preferred, or equivalent experience.
• Experience leading NPI programs for connected/electro-mechanical medical devices through full lifecycle.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, ISO 14971; partnered with regulatory/quality teams.

Responsibilities

• Manage cross-functional NPI programs from concept through design, verification and validation, transfer to manufacturing, and sustaining.
• Coordinate with hardware, firmware, mobile/app, regulatory, quality, and clinical teams to define requirements and timelines.
• Drive program risk management per ISO 14971 and communicate status and risks to leadership.
• Own schedules, DHF milestones, and phase-gate deliverables in partnership with quality/regulatory teams.
• Support design transfer and manufacturing readiness with operations and contract manufacturers.

Skills

Program management

Cross-functional leadership

Communication

Ownership

Education

Bachelor’s degree or higher

Tools

JIRA

Confluence

SmartSheet

Job description

Job Overview

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.

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.