Engineering Director at Inspire Medical Systems
Overview
Engineering Director leads manufacturing operations at Inspire Medical Systems. This mission‑critical role shapes future engineering functions and scales the organization. The ideal candidate builds teams systems and drives high‑visibility initiatives that strengthen product quality and accelerate innovation.
What You'll Do11
- 1Develop and execute engineering strategy aligned with business goals and manufacturing roadmap
- 2Lead mentor and grow high‑performing team across product development sustaining engineering and technical operations
- 3Build scalable engineering systems processes documentation and structure for future manufacturing footprint
- 4Serve as key technical voice on leadership team contributing to long‑range planning risk assessment and operational scale‑up
- 5Oversee all engineering activities across product lifecycle including concept development design verification validation and post‑market support
- 6Manage sustaining engineering efforts product enhancements field issue resolution cost reductions and design improvements
- 7Collaborate with Quality Regulatory Program Management and Clinical teams to ensure compliance with FDA ISO 13485 and other standards
- 8Oversee technical relationships with contract manufacturers suppliers and external partners driving process validation DFM/DFA and transfer‑to‑manufacturing readiness
- 9Drive root cause analyses CAPAs and risk mitigation with cross‑functional stakeholders
- 10Support commercial teams with technical expertise as needed
- 11Own engineering documentation technical files design control processes and ensure compliance with FDA QSR ISO 13485 IEC 60601
Requirements10
- 1Bachelor's degree in Mechanical Electrical Biomedical Engineering or related field
- 2Master's preferred
- 310+ years of engineering experience in medical device industry
- 45+ years in technical leadership managing cross‑functional engineering teams
- 5Proven success leading sustaining engineering and/or new product development programs under regulated design controls
- 6Experience with contract manufacturers and design transfer activities
- 7Strong understanding of FDA 21 CFR Part 820 ISO 13485 risk management ISO 14971 and V&V methodologies
- 8Ability to build processes mentor teams and drive cross‑functional alignment
- 9Background in scaling manufacturing equipment process development and validation
- 10Experience in growth‑stage or transformation‑stage environments
Salary Insight
Salary not disclosed in listing
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