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 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! ESSENTIAL JOB FUNCTIONS We are recruiting for a Senior Systems Engineer to join our rapidly growing Product Development team. In this role, you will work closely with our engineering team to develop software for our next generation Inspire products. OPPORTUNITIES YOU WILL HAVE IN THIS ROLE Provide systems expertise for existing products Engage in design reviews to ensure designs meet or exceed implementation, testing, scalability, and maintainability best practice guidelines Engage in design transfer activities to ensure the design has been properly transferred to manufacturing Support product risk management activities in compliance with ISO 14971 Support new product launch planning in partnership with operations, marketing, sales & education Monitoring product performance, complaint investigations, and supports evaluation of quality issues impacting released product Own system deliverables related to design changes for commercially released products. Supporting products or systems after their release by developing maintenance plans, scheduling regular updates, and managing teams. Represents the systems engineer function for technical problem solving including CAPA investigations and triaging issues. Provide technical knowledge and input into risk assessments when quality issues are being evaluated. Represents the product development function during inspections or audits from regulatory agencies (e.g. FDA, FDB, Notified Body). Demonstrate the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management. Create strategic plans for driving efficiencies and continuously improve function Provides feedback loop CAPAs and complaints as an input to new product development efforts WHAT YOU CAN BRING TO OUR GREAT TEAM Required: Bachelor's degree in biomedical, software, computer science, or related field. 4+ years (2+ years with Master's degree) of work experience in systems, software or signal processing Ability to efficiently specify, design, implement, verify, validate, and support high quality algorithms Experience developing in MATLAB, Python, and C++ languages or equivalent Preferred: Master's degree in biomedical, software, computer science, or related field. Medical device product development experience Understanding of systems engineering processes Understanding of embedded software development and testing Understanding of software and systems considerations for clinical research Experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, IEC 60601, IEC 62304, IEC 62366 etc. Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level. Salary $121,000 $182,000 USD BENEFITS AND OTHER COMPENSATION Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered): Multiple health insurance plan options. Employer contributions to Health Savings Account. Dental, Vision, Life and Disability benefits. 401k plan + employer match. Identity Protection. Flexible time off. Tuition Reimbursement. Employee Assistance program. All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program. 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, pregnancy or childbirth, 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.
