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 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! ABOUT THIS POSITION This position must provide expertise and leadership in the areas of medical device sterilization validation and microbiological monitoring. This position will work with contract manufacturers, contract sterilizers and Inspire Development, Operations, Manufacturing, and Quality functional areas to ensure sterilization and process monitoring are completed in accordance with Inspire procedures, industry standards and geographic regulations. In addition, this role must be flexible for changing priorities and able to work without direct supervision. OPPORTUNITIES YOU WILL HAVE IN THIS ROLE Develop initial product sterilization validation protocols, execute the protocols and generate validation reports. Complete annual sterilization validation reviews and generate supporting reports for Inspire sterilization cycles at contract manufacturers. Manage and coordinate testing activities for both bioburden and endotoxin monitoring. Audit contract sterilizers and contract manufacturing sites who manage sterilization of Inspire product as part of the supplier audit process. Generate audit plans and reports for those audits. Complete sterilization non-conformance and CAPA investigations, including those associated with contract manufacturers. Ensure sterilization and monitoring activities are in compliance with required regulatory standards (ISO 11135, 10993-7, 14971, etc.) Provide product and manufacturing support in cGMP regulated environments. Provide sterilization subject matter expertise to Quality, Operations and Development teams. Develop and validate test method protocols as needed. Manage future cleanroom qualifications and both microbiological and particulate monitoring activities. Perform environmental monitor sampling as required. Required Qualifications Bachelor's degree in Microbiology, Molecular Biology, Chemistry, Biochemistry, Biology or Biological Sciences 5 - 10 years minimum experience in sterilization or microbiology function in the finished medical device industry In-depth knowledge on the ethylene oxide (EO) sterilization process Experience demonstrating compliance with ISO 11135 and ISO 10993-7 Demonstrated team leadership skills and ability to prioritize, execute and report on projects Experience with GHTF requirements for process validations, etc. Strong project and time management skills Ability to work on multiple tasks concurrently with changing priorities Proficient with of MS Word, Excel and PowerPoint Preferred Qualifications Master's degree in Microbiology, Chemistry, Biochemistry or other related technical field Experience with cleanroom and microbiological monitoring Experience with Class III active implantables Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA. Knowledge on ISO and FDA/Quality System Requirements. (e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822 ISO 13485 certified auditor Physical Requirements: Ability to lift 30 lbs. 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.