Software Engineer - Medical Device Software
Inspire Medicalsystemsinc · Minneapolis, MN
About this role
**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 is committed to prioritizing patient outcomes, acting with integrity, and leading with respect—supported by a people-first culture and benefits including 401(k) matching, ESPP, flexible time off (FTO), and tuition reimbursement. --- **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 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; enhance existing components to ensure software meets business needs while complying with applicable regulations and processes (IEC 62304) - Assure compliance with industry applicable standards for medical devices - Ensure quality system, regulatory, legal, and business requirements are met throughout 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 prescribed timelines and provide necessary documents to complete investigations; 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 suggest continuous process improvements --- **QUALIFICATIONS** **Educational Requirements** - Bachelor’s Degree in Engineering, Software, Computer Science, or related discipline **Required Experience** - 2–4 years of 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; ability to communicate with internal/external stakeholders and senior leadership - Familiarity with FDA regulated software verification best practices **Preferred Experience** - Advanced degree in Engineering, Software, Computer Science, or related discipline - Experience working on Agile development teams and best practices - Familiarity with reviewing peers’ code in a collaborative development team - Medical device development cycle experience - Authorship of QMS / FDA regulated software documentation --- **LOCATION / WORK STYLE** - #LI-Onsite --- **SALARY (POSTING RANGE)** - **$90,000 – $120,000 USD** ---
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