Software Engineer - Medical Device Software

The role

The Software Engineer will work with Digital Solutions teams to develop applications for next generation Inspire products. This role involves building and deploying patient management and support services on Azure.

What you will do

• Build and deploy 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 and complies with IEC 62304
• Assure compliance with industry applicable standards for medical devices
• Ensure quality system, regulatory, legal, and business requirements are met
• 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, and engineering change order records
• Develop, disclose, and support the patenting of innovative technology and solutions

Required qualifications

• Bachelor’s Degree in Engineering, Software, Computer Science, or related discipline
• 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
• Familiarity with FDA regulated software verification best practices

Nice to have

• 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

Benefits

• 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
• Equity awards
• Employee Stock Purchase Program

About the company

Inspire Medical Systems is a medical device company that develops products for those living with Obstructive Sleep Apnea (OSA). The company is committed to enhancing patients' lives through sleep innovation.