Manufacturing Engineer

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

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, 401(k) 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!

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

CFR 820 GMP experience.

• Provide expert technical support for manufacturing operations to meet or exceed goals.
• Develop and implement process and product improvements, typically for complex scope and wide magnitude projects.
• 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 production support and troubleshooting, addressing issues arising on the production floor and leading interdisciplinary teams to resolve high‑profile production issues and document corrective actions using quality systems procedures (NCMR & CAPA). Ability to lead failure investigations.
• Ensure processes and procedures comply with internal procedures, GMP, and global regulations.
• Process validation: develop master validation plans to evaluate process repeatability and stability through IQ/OQ/TMV and PQ processes.
• Equipment and fixturing: determine specific requirements of manufacturing operation to specify equipment, fixturing, and process parameters; collaborate on design with suppliers to fulfil requirements.
• Support transfer of new products and processes from process development to manufacturing, serving as technical manufacturing expert to provide feedback during the development cycle and represent operations during introduction into manufacturing, initial ramp, and stabilization of processes.
• Design manufacturing processes, procedures, and 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 and specify procedures for fabrication of tools, equipment, and other functions that affect product performance.

• Document product and therapy related field reports within the 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.

• BS degree in an Engineering discipline (Manufacturing, Mechanical, Industrial, etc.)
• Minimum of 1‑2 years of relevant experience
• 1‑2 years of increasingly complex engineering responsibilities in a manufacturing environment

• MS degree in an Engineering…