Systems Test Engineer

Systems Test 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 We are recruiting a Systems Test Engineer to join our team located in the Minneapolis, MN location. In this role, you will be synthesizing customer needs, business needs, and technology expertise into a system design, product development and implementation plans for the next generation of Inspire products. You will also provide functional technical leadership for system and product verification and validation testing as well as support continuation engineering as required. Responsibilities: Develop and manage tools and methods to organize, lead and report on system and product testing for multiple concurrent projects Lead new product development teams to design, implement and validate test environments and methods Work closely with system and lead engineers to understand the specifics of the software applications, the hardware and the operating platform on which the applications run Read, analyze, understand and support requirements reviews from user needs down to software requirements Support test infrastructure set up and test method validation (e.g. gage R&R) Drive test planning and be able to articulate the most appropriate method to verify a particular feature or function Provide training and mentorship to junior and contract engineers on test planning, development and execution Provide system design, electrical and software expertise for new products as well as changes to existing products Lead product design reviews for products in development as well as continuation Provide continuation engineering support for products as assigned Assure compliance with industry applicable standards for medical devices Generate and approve design history file documents, device master record documents and engineering change order records Ensure all quality system, regulatory, legal, and business requirements are met during product development and market delivery Support post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations. Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement Required Qualifications: Bachelors Degree in Biomedical, Software, Electrical Engineering, or related discipline or 10 years of related experience in lieu of degree 3 years of engineering experience from a regulated industry (i.e. aerospace, healthcare, pharmaceuticals, etc) Demonstrated experience defining, leading and managing system and product testing Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior leadership Proficient with MS Suite (Word, Excel, Outlook) Preferred Qualifications: Advanced level degree in Biomedical, Software, Electrical Engineering, or related discipline Experience with implantable medical product development Experience with test utomation Previous software and/or firmware development experience, including Python, .NET, and/or CAD software Demonstrated understanding of any or all of the following: Electrical safety testing and the corresponding standards 21 CFR 820 requirements ISO 13485 requirements for design, development, and manufacturing ISO 14971 ISO 14708 EN 45502 ISO/IEC 60601 Manufacturing process validation activities (IQ/OQ/PQ) Understanding of systems engineering best practices and how they apply to continuous process improvement usability standards and integration into the product development process 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. 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.