Director Operations Engineering

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! Position Overview The Engineering Director is a mission‑critical leader who will shape the future of our Manufacturing Operations. Reporting directly to the Vice President of Operations & Supply Chain , this role will champion all engineering functions and play a defining role in scaling the organization for its next stage of growth. This leader will provide strategic, operational, and technical direction across the engineering organization guiding teams through sustaining engineering activities, building a robust continuous improvement pipeline, and partnering closely with R&D to bring next‑generation products to market. They will drive high‑visibility initiatives that strengthen product quality, accelerate innovation, and prepare the company for an expanded manufacturing footprint. The ideal candidate is a builder of teams, systems, and capability. They bring the discipline to implement scalable processes, the foresight to elevate our engineering culture, and the leadership presence to influence decisions at the highest levels of the company. They will play a pivotal role in developing future technical talent, expanding product capabilities, and ensuring compliance within a regulated medtech environment. This is a rare opportunity to make a transformative impact shaping the technical foundation, operational readiness, and long‑term growth of a rapidly expanding organization. Key Responsibilities Strategic & Leadership Responsibilities Develop and execute the engineering strategy in alignment with the company’s business goals and long‑term manufacturing roadmap. Lead, mentor, and grow a high‑performing team across product development, sustaining engineering, test engineering, and technical operations. Build scalable engineering systems, processes, documentation, and organizational structure suitable for a future manufacturing footprint. Serve as the key technical voice on the leadership team, contributing to long‑range planning, risk assessment, and organizational readiness for operational scale‑up. Product Development & Sustaining Engineering Oversee all engineering activities across the product lifecycle, including concept development, design, verification/validation, risk management, and post‑market support. Lead teams in executing New Product Development (NPD) programs from concept to commercialization in compliance with FDA, ISO 13485, and other relevant regulatory requirements. Manage and prioritize sustaining engineering efforts, including product enhancements, field issue resolution, cost reductions, and design improvements. Collaborate closely with Quality, Regulatory, Program Management, and Clinical teams to ensure products meet safety, performance, and compliance requirements. Manufacturing Readiness & External Partnerships Oversee technical relationships with contract manufacturers (CMOs), s…