Senior Software Engineer

Position Responsibilities

This role combines advanced software engineering with compliance-driven development practices within a highly regulated medical device environment. The successful candidate will contribute to the design, implementation, verification, and documentation of software solutions while ensuring alignment with quality and regulatory requirements.

• Design, develop, test, and support software features across the client's platform and related systems.
• Translate software functionality into clear, testable, and maintainable requirements.
• Create and maintain software design specifications and architecture documentation.
• Develop verification plans, traceability artifacts, and supporting compliance documentation.
• Participate in risk management activities including hazard analysis and FMEA exercises.
• Ensure consistency between requirements, implementation, testing, and release documentation.
• Collaborate with Quality Assurance and cross-functional stakeholders to support product releases.
• Identify documentation gaps and implement process improvements across engineering workflows.
• Mentor team members on requirements development, traceability, and documentation best practices.
• Participate in code reviews, technical design discussions, and complex system debugging efforts.
• Support adherence to quality system requirements and regulatory expectations.

• 5+ years of professional software engineering experience.
• Experience working within regulated industries such as medical devices.
• Experience developing and supporting complex integrated software systems.
• Demonstrated debugging, troubleshooting, and problem-solving capabilities.
• Ability to create clear technical documentation from software implementations.
• Experience balancing software development responsibilities with compliance documentation requirements.
• Strong communication skills and ability to collaborate across multidisciplinary teams.

• Familiarity with IEC 62304, ISO 14971, or related regulatory standards.
• Experience with requirements management and traceability processes.
• Knowledge of software design documentation including SDS and SAD deliverables.
• Experience supporting risk management documentation and verification planning activities.
• Exposure to audits, regulatory submissions, or quality system processes.
• Experience mentoring engineers and driving process improvement initiatives.

• Competitive salary plus a comprehensive benefits package.
• Health coverage, retirement plans, and other company-sponsored perks.
• Generous paid time off, including holidays, to support work-life balance.
• Flexible schedules and work life balance.
• Strong focus on employee development with on-the-job training and career growth.
• A positive company culture that values diversity and collaboration.

The pay range for this role is:

100, USD per year (Minneapolis, MN)