Senior Medical Device Software Engineer

The Senior Medical Device Software Engineer will own the Testworks software platform and lead the full software development lifecycle within a regulated medical device environment, employing C# and .NET. The role may support firmware development for Class I or II devices as needed and is based in a hybrid setup in Saint Paul, Minnesota.

Responsibilities

• Act as the primary developer and technical owner of the Testworks medical device software platform.
• Design, implement, test, document, and maintain Testworks using C# and .NET.
• Steer software architecture decisions and set technical direction for the platform in collaboration with hardware engineers, sales, and support teams.
• Create new software capabilities and refactor existing code to enhance performance, usability, reliability, and maintainability.
• Validate software with the WR Medical suite of devices.
• Produce and maintain software requirements, design documentation, test protocols, traceability, and validation records.
• Plan and execute software verification and validation activities in accordance with medical device quality systems and regulatory requirements.
• Participate in software risk management and design control activities.
• Provide occasional technical assistance to customers.
• Review post-market surveillance and complaint feedback and integrate insights into the software lifecycle.
• Support firmware development efforts for Class I and Class II medical devices as needed, including collaboration with external firmware development consultants.

Requirements

• Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, or a related technical field.
• At least 5 years of software development experience.
• Experience developing software within a regulated medical device environment.
• Experience documenting and executing software verification and validation in a medical device or similarly regulated setting.
• Strong proficiency in C# and .NET development.
• Track record in developing software from concept through release and in refactoring and maintaining existing applications.
• Ability to work independently and take ownership of software products.
• Authorized to work in the United States without sponsorship.
• Ability to work onsite in Maplewood, MN at least three days per week.

Technologies

• C#
• .NET

Benefits

• Remote work two days per week
• Flexible scheduling with core hours from 9:00 to 15:00
• Medical insurance
• Dental coverage
• 401(k) matching
• Yearly bonus
• Paid time off and holidays
• Low merge-conflict environment with clear code ownership

Position Summary

WR Medical Electronics Co operates in Maplewood, Minnesota, with two business units: Therabath, which produces paraffin wax baths and related products, and Neuro, which offers a suite of neuropathy testing devices connected through the Testworks software platform. The company seeks an experienced Senior Medical Device Software Engineer to serve as the primary developer and technical owner of the Testworks platform, responsible for the full software development lifecycle.

Preferred Qualifications

• Experience developing and validating Software as a Medical Device (SaMD).
• Familiarity with embedded software or firmware development.

Pay

Salary: USD 90,000 - 120,000 per year

Work Location

Hybrid remote in Saint Paul, MN 55109