Senior Manufacturing Engineer

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, prioritizing patient outcomes, acting with integrity, and leading with respect.

At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices, encourage learning opportunities, and build a professional network that grows into a community. We embrace a people‑first culture by offering excellent benefits, 401(k) matching, ESPP, flexible time off (FTO), and tuition reimbursement.

The Senior Engineer will support end products built by multiple contract manufacturing facilities. This role focuses on resolving manufacturing issues and improving throughput and yields to maintain product supply to meet demand. The successful candidate will demonstrate knowledge related to working in a regulated industry with ISO 13485 and 21

CFR 820 GMP experience.

• Provide expert technical support for manufacturing to meet or exceed goals
• Develop and implement process and product improvements
• Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned
• Generate all required documentation in support of manufacturing test protocols and reports, using appropriate statistical support and Design of Experiments (DOE) when developing recommendations
• Provide engineering support for manufacturing operation, addressing related issues arising on the production floor
• Lead inter‑disciplinary teams to resolve high‑profile production issues and document recommended corrective actions using the quality systems procedures (NCMR & CAPA)
• Ensure processes and procedures are in compliance with internal procedures, GMP, and global regulations
• Lead process validation, develop master validation plans to evaluate process repeatability and stability through IQ/OQ/TMV and PQ processes
• Specify equipment, fixturing, and process parameters, collaborating on design with suppliers as needed
• Support transfer of new products and processes from development to manufacturing, providing feedback during development cycles and representing operations during introduction, ramp, and stabilization
• Design manufacturing processes, procedures, production layouts for assemblies, equipment installation, processing, machining, and material handling
• Design arrangement of machines within plant facilities to ensure most efficient and productive layout
• Design sequence of operations, specifying procedures for the fabrication of tools and equipment and other functions that affect product performance

• Document product and therapy‑related field reports within prescribed timelines and provide any necessary documents required to complete the investigation
• Provide follow‑up reporting as needed
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement

Required:

• B.S. degree in an Engineering discipline (Manufacturing, Mechanical, Industrial, etc.)
• Minimum of 7+ years of relevant experience
• 5+ years of increasingly complex engineering responsibilities in a manufacturing environment

Preferred:

• M.S. degree in an Engineering discipline
• Minimum of 7+ years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
• 5+ years of increasingly complex engineering responsibilities in a manufacturing environment
• 5+ years of experience working within 21
  
  CFR 820 & ISO 13485 compliant manufacturing environments
• Engineering experience with active implantable medical devices

$109,000 - $163,000 USD

• Multiple health insurance plan options
• Employer contributions to Health Savings Account
• De…