Director Operations Engineering

Job description

**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), suppliers, and external development partners. - Drive process validation, DFM/DFA efforts, and transfer-to-manufacturing readiness activities. - Develop and maintain strong supplier-quality and technical oversight processes. **Cross-Functional Collaboration** - Partner with Operations, Supply Chain, Quality, and Regulatory teams to ensure smooth product launches and ongoing production stability. - Lead root cause analyses (RCAs), CAPAs, and risk mitigation efforts with cross-functional stakeholders. - Support commercial teams and customer-facing functions with technical expertise as needed. **Process, Quality & Compliance** - Own engineering documentation, technical files, and design control processes. - Ensure engineering deliverables comply with FDA QSR, ISO 13485, IEC 60601, and other applicable standards for medical devices. Strengthen the company’s design controls, requirements management, and change control procedures. **Qualifications** **Required** - Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field; Master’s preferred. - 10+ years of engineering experience in the medical device industry. - 5+ years in technical leadership roles, managing cross-functional engineering teams. - Proven success leading **Sustaining Engineering** and/or **NPD** programs under regulated design controls. - Experience working with contract manufacturers and leading design transfer activities. - Strong understanding of FDA 21 CFR Part 820, ISO 13485, risk management (ISO 14971), and V&V methodologies. - Demonstrated ability to build processes, mentor teams, and drive cross-functional alignment. **Preferred** - Experience in scaling manufacturing capabilities, including equipment procurement, process development, and validation. - Background in complex electromechanical systems, wearable devices, diagnostics, or therapeutic devices. - Strong systems engineering and root‑cause problem‑solving skills. - Experience in a growth-stage or transformation-stage environment. #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 $170,000—$240,000 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, genetic information, pregnancy or childbirth, 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*](https://www.inspiresleep.com/wp-content/uploads/2016/07/EEO.pdf)*employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com* *Inspire Medical Systems participates in E-Verify.*