Program Manager, NPI

🕒 September 9

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

📋 Program Manager

👻 Ghost score 26%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 64 days.
• No salary listed.

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Willow Innovations, Inc.

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51 - 200 employees

🧘 Wellness

🏥 Healthcare

👥 B2C

Wellness • Healthcare • B2C

Willow Innovations, Inc. is a pioneering company recognized for its innovative breast pumps, notably selected as one of TIME’s 25 Best Inventions. Their flagship product, the Willow pump, is designed to eliminate the need for traditional components like bottles and motors, offering a unique in-bra and app-connected solution that empowers mothers with a more comfortable pumping experience. Willow is focused on enhancing the convenience and ease of breastfeeding through advanced wellness technology.

📋 Description

• Manage complex cross-functional NPI programs for connected medical devices from concept through design, verification and validation, manufacturing transfer, and sustaining • Collaborate with hardware, firmware, mobile/app, regulatory, quality, and clinical teams to define requirements, priorities, scope, budget, and timelines • Drive program-level risk management per ISO 14971 • Own program schedules, design history file milestones, and phase-gate deliverables • Resolve issues, remove obstacles, and facilitate cross-team decision-making • Coordinate Bluetooth/BLE, companion app, and cloud/data integration workstreams with software and security teams • Develop recommendations, gain stakeholder alignment, and communicate program status and risks to leadership • Support design transfer and manufacturing readiness with operations and contract manufacturers

🎯 Requirements

• 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 • 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 and Confluence • Ability to communicate technical problems and solutions clearly to diverse audiences • Strong familiarity with project management software tools, methodologies, and best practices • PMP or PgMP certification preferred • Strong sense of ownership, urgency, and drive • Agile project management style, approach, and execution

🏖️ Benefits

• Equal employment opportunities regardless of gender, race, religion, sexual orientation, gender identity, age, marital status, disability, or Veteran status

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