Program Manager, Operations

Inspire Medical Systems • Minneapolis, MN

1d • $120,000 - $165,000 • Onsite

About The Position

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve. At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team! As our Program Manager, Operations, you will lead complex, cross-functional programs that span product lifecycle management, supplier readiness, contract manufacturing, quality compliance, cost optimization, and post-market performance. You will act as the primary operational integrator—ensuring our contract manufacturers (CMs), suppliers, and internal teams deliver high-quality, compliant products on time and at scale. You’ll partner closely with Quality, Regulatory, Supply Chain, R&D, Finance, and Commercial to ensure seamless execution from development through commercialization and sustaining.

Requirements

• 7+ years of program/project management experience in medical devices or highly regulated hardware environments.
• Demonstrated success managing programs that include contract manufacturers, external suppliers, or global supply chains.
• Strong understanding of QMS and regulatory frameworks: 21 CFR 820, ISO 13485, ISO 14971, design controls, validation, DHF/DMR.
• Experience with change control, BOM/part transitions, and ERP/PLM-driven lifecycle management (e.g., Agile, Arena, SAP, Oracle).
• Strong communication, influencing, and cross-functional leadership skills—especially in environments where you lead through others without direct authority.

Nice To Haves

• Bachelor’s degree in Engineering, Operations, Supply Chain, or related field; advanced degree a plus.
• PMP, Lean Six Sigma (Green/Black Belt), or similar credentials.
• Experience with global CMs and suppliers, including Mexico-based manufacturing partners.
• Familiarity with DFM/DFA, reliability engineering, component cost modeling, and electronic/mechanical assembly environments.

Responsibilities

• Program Leadership & Execution Lead cross-functional programs that span NPI, product changes, cost reductions, supplier transitions, and lifecycle management.
• Own integrated program plans (scope, schedule, budget, risk, resources) and maintain alignment across internal teams and external partners.
• Drive stage-gate readiness, coordinate executive reviews, and deliver on time, cost, quality, and compliance targets.
• Outsourced Manufacturing & Supplier Management Serve as the primary operations interface to contract manufacturers and key suppliers.
• Coordinate production planning, capacity modeling, ramp timing, inventory strategy, and continuity-of-supply plans with external partners.
• Oversee readiness activities including process validation support, capability assessments, FAI/PPAP (as applicable), line qualification, and change implementation at suppliers and CMs.
• Manage supplier- and CM-driven programs such as tooling refresh, yield improvement, and line transfers.
• Quality, Compliance & Risk Management Ensure all programs comply with 21 CFR 820, ISO 13485, ISO 14971, and design control requirements in an outsourced environment.
• Partner with Quality and Regulatory to integrate risk management, V&V strategies, and documentation deliverables into program timelines.
• Support supplier and CM audits, inspection readiness, and corrective action plans; ensure CAPA and complaint insights are fed back into sustaining programs.
• Sustaining Engineering & Cost Optimization Lead VAVE and COGS reduction initiatives, including supplier consolidation, component redesign, BOM cost modeling, and process improvements at CMs.
• Drive engineering change orders (ECOs), configuration control, and ERP/PLM updates to support a fully outsourced supply chain.
• Facilitate troubleshooting and root-cause analysis for supplier or CM issues impacting quality, yield, throughput, or field performance.
• Cross-Functional Alignment & Communication Deliver clear, proactive communication to the VP of Operations and senior stakeholders on program status, critical path, risks, and resource needs.
• Prepare dashboards and metrics for program governance and executive reviews.
• Build effective relationships with CM leaders, supplier contacts, and internal technical teams.

Benefits

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees