Software Engineer - Medical Device Software

Inspire therapy • Minneapolis, MN

1d • Onsite

About The Position

Inspire Medical Systems is hiring a Software Engineer to work closely with the Digital Solutions teams in Minneapolis, Minnesota. The engineer will collaborate with engineers and scientists to develop applications for next-generation Inspire products, including patient management and support services deployed on Azure. The role also contributes to regulated medical-device software development, ensuring solutions meet business needs and applicable regulatory, quality, security, and risk-management requirements.

The position involves testing, debugging, documenting, and integrating software; maintaining software components; managing source and executable code; and creating or approving quality-system and product records. The engineer may also support Inspire customers and contribute to the disclosure and patenting of innovative technology. Quality-system duties include documenting product- and therapy-related field reports, completing required training and competency confirmations, following applicable procedures, and suggesting process improvements.

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 and standards such as IEC 62304, IEC 82304-1, or 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 with 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/or other supporting languages.
• Assist with system, software, security, and risk-management documents.
• Test, debug, and document integration solutions and enhance existing components so software meets business needs and complies 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, disclose, and support the patenting of innovative technology and solutions.
• Document product- and therapy-related field reports within prescribed timelines, provide necessary investigation documents, and submit follow-up reporting as needed.
• Complete required training and competency confirmations within the required timeline.
• 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 for employees at all levels to participate in company ownership and success through equity awards and the Employee Stock Purchase Program.

What This Job Offers

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