Senior Medical Device Software Engineer

Position Summary

WR Medical is a small medical device manufacturer in Maplewood, Minnesota split into two business units. Therabath manufactures paraffin wax baths and wax. Neuro manufactures a suite of neuropathy testing devices tied together with the Testworks software platform.

We are seeking an experienced Senior Medical Device Software Engineer to serve as the primary developer and technical owner of our Testworks software platform. This role is responsible for the full software development lifecycle, including architecture, design, implementation, testing, validation, maintenance, and continuous improvement of a C#/.NET application used in a regulated medical device environment.

The successful candidate will have experience developing and validating medical device software, be comfortable working independently, and have a proven track record of building new software systems as well as refactoring and modernizing existing applications. Experience with Software as a Medical Device (SaMD) is highly preferred.

This position may also support firmware development activities for Class I and Class II medical devices. Direct firmware development experience is not required, as external firmware development resources are available for consultation when needed.

This is a hybrid role where the engineer will need to be able to work on site an average of 3 days a week in order to test the software interface with hardware.

Responsibilities

The essential functions include, but are not limited to the following:

· Serve as the primary developer and technical owner of the Testworks medical device software platform.

· Design, develop, test, document, and maintain Testworks using C# and .NET.

· Lead software architecture decisions and establish technical direction for the platform in conjunction with hardware engineers, sales, and support staff.

· Develop new software functionality and refactor existing code to improve performance, usability, reliability, and maintainability.

· Test software with the WR Medical suite of devices.

· Create 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 system and regulatory requirements.

· Participate in software risk management and design control activities.

· Provide occasional technical assistance for customers.

· Review and integrate post-market surveillance/complaint feedback.

· Support firmware development efforts for Class I and Class II medical devices as needed, including collaboration with external firmware development consultants.

Required Qualifications

· Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, or a related technical field.

· 5+ years of software development experience.

· Experience developing software in a regulated medical device environment.

· Experience creating and executing software verification and validation documentation in a medical device or similarly regulated setting.

· Strong proficiency in C# and .NET development.

· Experience developing software from concept through release.

· Experience refactoring and maintaining existing software applications.

· Ability to work independently and take ownership of software products.

· Authorization to work in the United States without sponsorship

· Ability to work on site in Maplewood, MN at least 3 days a week.

Preferred Qualifications

· Experience developing and validating Software as a Medical Device (SaMD).

· Familiarity with embedded software or firmware development.

Benefits

· Ability to work remote 2 days/week

· Flexible scheduling (core hours 9-3)

· Medical

· Dental

· 401k matching

· Yearly bonus

· PTO & paid holidays

· Low merge-conflict environment – the code is all yours

Pay: $90,000.00 - $120,000.00 per year

Benefits:

401(k)

401(k) 6% Match

Dental insurance

Flexible schedule

Flexible spending account

Health insurance

Health savings account

Paid time off

Work Location: Hybrid remote in Saint Paul, MN 55109