Sr. Program Manager

Inspire Medical Systems Inc. • Minneapolis, MN

2h • $180,000 - $220,000 • Onsite

About The Position

Inspire Medical Systems is seeking an experienced, strategic Senior Program Manager to lead cross-functional execution of next-generation neurostimulator development programs through design verification and validation, FDA submission and approval, and commercial launch. The role is the central leader for planning, coordinating, and driving one or more critical product development initiatives. It works across product development and the wider organization to build plans, align teams, manage risks, meet milestones, and optimize resources and budgets across concurrent projects.

The role includes program and project leadership, risk management, coordination of product development execution, and partnership with Regulatory Affairs and Quality Assurance on regulatory and quality requirements. The Senior Program Manager also leads launch-readiness coordination across Marketing, Commercial, Clinical, and Customer Service, establishes launch metrics and readiness criteria, and monitors launch execution and post-market stabilization. The position contributes to the development of PMO practices and mentors team members and functional managers.

Inspire describes its FDA-approved medical device as designed to reduce obstructive sleep apnea severity for people who cannot tolerate CPAP or do not receive consistent benefit from it. The company says it is committed to improving patient outcomes through sleep innovation.

Requirements

• Bachelor's degree in Engineering, Science, Business, or a related field.
• At least 10 years of relevant project or program management experience.
• At least 4 years leading complex medical-device development projects.
• Demonstrated success leading products from development through regulatory approval and commercial launch.
• Ability to lead multiple concurrent projects and cross-functional teams without direct authority.
• Experience with FDA submissions for Class II and/or Class III medical devices.
• Strong communication, stakeholder-engagement, and strategic-planning skills, including presenting to executive leadership.
• Proficiency with program-management tools such as Microsoft Project, Smartsheet, and AI.
• Strong understanding of design controls, the product development lifecycle, design verification and validation, FDA regulatory processes, and quality systems.

Nice To Haves

• Experience with implantable medical devices.
• Experience with neurostimulation products.
• Experience with electromechanical medical systems.
• Experience with program-management methodologies including Agile and Stage-Gate development models.
• Experience in PMO and portfolio-governance environments.
• Led at least one major medical-device program from proof of concept through pilot production and market introduction.
• Experience using generative AI for tasks such as meeting minutes, dashboarding, reporting, and communications.
• Experience managing budgets, timelines, and risks under contractual commitments with external development partners.
• PMP, PgMP, or equivalent program-management certification.
• Master's degree in Engineering, Science, Business, or a related field.

Responsibilities

• Lead new-product design and integration from design verification and validation through FDA approval and commercial launch.
• Develop and maintain integrated project plans, schedules, critical-path analyses, and resource forecasts.
• Create and monitor program budgets with functional leaders, driving cost efficiency and financial accountability.
• Drive project governance, phase-gate reviews, and project-team decision-making.
• Partner with internal and external stakeholders to define and manage program scope and strategic priorities, aligning teams on objectives, risks, timelines, and business outcomes.
• Contribute to PMO growth and maturity by standardizing program-management practices, tools, and templates.
• Coach and mentor project-team members and functional managers in program and risk-management practices.
• Build and execute communication plans for project teams, stakeholders, and executive leadership.
• Develop and maintain program risk-management plans, risk logs, and escalation processes.
• Identify, assess, and mitigate technical, clinical, regulatory, and launch risks; lead cross-functional risk reviews and executive escalations.
• Develop contingency plans for critical-path activities.
• Coordinate design-verification activities and monitor completion of design inputs, outputs, verification protocols, test reports, and technical documentation for the design history file.
• Partner with engineering teams to ensure technical deliverables are completed on schedule and facilitate cross-functional issue resolution.
• Coordinate preparation of FDA submission packages with the Regulatory team and partner with Regulatory Affairs and Quality Assurance to ensure compliance with applicable requirements.
• Coordinate launch planning across Marketing, Commercial, Clinical, and Customer Service.
• Establish launch-success metrics and readiness criteria, drive completion of launch deliverables and executive launch approvals, and monitor launch execution and post-market stabilization.

Benefits

• Multiple health insurance plan options.
• Employer contributions to a Health Savings Account.
• Dental, vision, life, and disability benefits.
• 401(k) plan with employer match.
• Identity protection.
• Flexible time off.
• Tuition reimbursement.
• Employee Assistance Program.
• Opportunity for employees at all levels to participate in company ownership and success through equity awards and the Employee Stock Purchase Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior