Software Engineer - Medical Device Software

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! POSITION SUMMARY The Software Engineer will work closely with the Digital Solutions teams located in the Minneapolis, MN location. As an integral part of our development team, this position will work closely with our engineers and scientists to develop applications for our next generation Inspire products. MAIN DUTIES/RESPONSIBILITIES Build and deploy cutting edge patient management and support services on Azure using .NET Core, C#, Python, and/or other supporting languages Assist with system, software, security, and risk management documents Test, debug, and document integration solutions and enhance existing components to ensure that software meets the business needs, while in compliance with applicable regulations and processes (IEC 62304) Assure compliance with industry applicable standards for medical devices Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery Create, control, and store software source and executable code Support Inspire customers as assigned. Generate and approve design history file documents, device master record documents, engineering change order records, and other quality system documents and records as assigned. Develop, disclose, and support the patenting of innovative technology and solutions. QUALITY SYSTEM RESPONSIBILITIES Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed. Complete training requirements and competency confirmations as required for this position within the required timeline. Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement. QUALIFICATIONS Educational Requirements: Bachelor’s Degree in Engineering, Software, Computer Science, or related discipline Required Experience: 2-4 years’ experience with .NET development in C# or similar object-oriented language Experience with Azure deployment tools and build processes for downloadable software Familiarity with Software as a Medical Device (SaMD) regulations such as IEC 62304 or IEC 82304-1, ISO 13485 Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior department leadership Familiarity with FDA regulated software verification best practices Preferred Experience: Advanced level degree in Engineering, Software, Computer Science, or related discipline Experience working on Agile development teams and best practices Familiarity with reviewing peer’s code in a collaborative development team Medical device development cycle experience Authorship of QMS / FDA regulated software documentation #LI-OnsiteThe 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$90,000—$120,000 USDBENEFITS 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 an equal opportunity employer 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.