Senior Program Manager, Connected Medical Devices

Willow group

Northern (KY)

Hybrid

USD 120,000 - 160,000

Full time

2 days ago

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Job summary

Willow is seeking an experienced Program Manager to lead new product introduction (NPI) for connected medical devices. You will collaborate with hardware, firmware, software, regulatory/quality, clinical, and manufacturing teams to drive requirements, design controls, and feasible plans from concept to launch and sustaining.

The role requires deep experience in regulated hardware/software, ISO 14971 risk management, and strong communication across diverse stakeholders.

Qualifications

12+ years of experience, with 5+ years of 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, 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.
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.

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 (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.