Sr. 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. Our focus on patient outcomes is at the core of everything we do, and our “think I can” attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments. 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 hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. If youre passionate about making a difference in peoples lives and want to work with innovative technology, come be a part of our great team! ABOUT THIS POSITION 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 objectives. 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 transfer of new products and processes from process development to operations. Serve as the technical manufacturing expert to provide feedback during the development cycle and represent operations with the 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 specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Required Qualifications B.S. degree in an Engineering discipline (Manufacturing, Mechanical, Industrial, etc.) Minimum of 1-2 years of relevant experience 1-2 years increasingly complex engineering responsibilities in a manufacturing environment Preferred Qualifications M.S. degree in an Engineering discipline Minimum of 1-2 years of relevant experience, or advanc d degree with a minimum of 5 years of relevant experience 5 years increasingly complex engineering responsibilities in a manufacturing environment Engineering experience with active implantable medical devices 5 years experience working within 21 CFR 820 & ISO 13485 compliant manufacturing environments 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, 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 anequal opportunityemployer 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. #LI-AM1 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 with regard to public assistance, membership or activity in a local commission, military or veteran status, genetic information, 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 employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 763-235-6742 or email careers@inspiresleep.com.