Program Manager, NPI

Willow Innovations, Inc.; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Willow Innovations, Inc. is seeking an experienced Program Manager to lead new product introduction (NPI) for 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. You will drive requirements gathering, design controls, and technical feasibility, and execute cross-functional plans to hit milestones from concept through launch and

Qualifications

• 12+ years of experience in program management.
• 5+ years of PM in medical devices or regulated hardware/software.
• Experience leading NPI programs for connected medical devices.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, ISO 14971.
• Bachelor's degree or higher preferred.

Responsibilities

• Manage complex cross-functional NPI programs for connected medical devices from concept through design, verification/validation, transfer to manufacturing, and sustaining.
• Collaborate with hardware, firmware, software, regulatory/quality, clinical, and manufacturing teams to define requirements, priorities, scope, budget, and timelines.
• Manage risk per ISO 14971 by identifying, assessing, and mitigating regulatory and schedule risks across the lifecycle.
• Own program schedules, DHF milestones, and phase-gate deliverables with quality and regulatory teams.
• Coordinate device connectivity workstreams (Bluetooth/BLE, companion app, cloud/data integration) with software/security teams for a cohesive UX.

Skills

Program management

Cross-functional leadership

Regulatory knowledge

Project lifecycle management

Communication

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. 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.