Software Engineer - Medical Device Software

Inspire Medical Systems Inc. • Minneapolis, MN

17h • $90,000 - $120,000 • Onsite

About The Position

The Software Engineer works closely with the Digital Solutions teams in Minneapolis, Minnesota, and collaborates with engineers and scientists to develop applications for next-generation Inspire products. The role builds and deploys patient management and support services using Azure and technologies such as .NET Core, C#, and Python. It also supports software integration, testing, documentation, regulatory compliance, quality-system activities, and customer support for medical-device software.

Requirements

• Bachelor’s degree in Engineering, Software, Computer Science, or a related discipline.
• 2–4 years of experience with .NET development in C# or a similar object-oriented language.
• Experience with Azure deployment tools and build processes for downloadable software.
• Familiarity with Software as a Medical Device regulations, such as IEC 62304 or IEC 82304-1, and ISO 13485.
• Strong written and verbal communication skills, including the ability to communicate with internal and external stakeholders and senior department leadership.
• Familiarity with FDA-regulated software verification best practices.

Nice To Haves

• Advanced degree in Engineering, Software, Computer Science, or a related discipline.
• Experience working on Agile development teams and knowledge of Agile best practices.
• Familiarity with reviewing peers’ code in a collaborative development team.
• Medical-device development-cycle experience.
• Authorship of QMS or FDA-regulated software documentation.

Responsibilities

• Build and deploy patient management and support services on Azure using .NET Core, C#, Python, and other supporting languages.
• Assist with system, software, security, and risk management documentation.
• Test, debug, and document integration solutions, and enhance existing components to meet business needs and comply with applicable regulations and processes, including IEC 62304.
• Assure compliance with applicable industry standards for medical devices.
• Ensure quality-system, regulatory, legal, and business requirements are met during 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 assigned quality-system documents and records.
• Develop and disclose innovative technology and solutions, and support their patenting.
• Document product- and therapy-related field reports within prescribed timelines and provide documents needed to complete investigations, including follow-up reporting as needed.
• Complete required training and competency confirmations within required timelines.
• Comply with applicable quality-system procedures and policies and suggest continuous process improvements.

Benefits

• Multiple health insurance plan options.
• Employer contributions to a Health Savings Account.
• Dental, vision, life, and disability benefits.
• 401(k) plan with employer match.
• Identity protection.
• Flexible time off.
• Tuition reimbursement.
• Employee Assistance Program.
• Opportunity to participate in company ownership through equity awards and the Employee Stock Purchase Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level