Software Engineer - Medical Device Software

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

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