ABOUT INSPIRE MEDICAL SYSTEMS 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. WHY JOIN OUR FAST-GROWING TEAM 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! ESSENTIAL JOB FUNCTIONS 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. OPPORTUNITIES YOU WILL HAVE IN THIS ROLE 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. What You'll Bring Required 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. Preferred 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. #LI-Onsite The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level. Salary $120,000 $165,000 USD BENEFITS AND OTHER COMPENSATION Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered): 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. Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status,... For full info follow application link. Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status with regard to public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis. Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 763-235-6742 or email careers@inspiresleep.com.
