Manufacturing Engineer

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 

ESSENTIAL JOB FUNCTIONS 

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 ISO13485 & 21CFR 820 GMP experience.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE 

• Provide expert technical support for Manufacturing to meet or exceed goals and
• Develop and implement process and product improvements. Typically, projects of
• complex scope and wide magnitude.
• 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. Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
• Production Support and Trouble Shooting: Provide engineering support to
• manufacturing operation. Address 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). Ability to lead Failure Investigations.
• Ensures processes and procedures are in compliance 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 in order to specify equipment, fixturing, and process parameters. May collaborate on design with suppliers to fulfill equipment and fixturing requirements.
• Support the