Senior Software Engineer

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.

Do you have experience in Technical writing within technology?, * 5+ years of professional software engineering experience.

• Experience working within regulated industries such as medical devices.
• Strong proficiency in C#, Python, JavaScript, or similar programming languages.
• 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.

Preferred Requirements:

• 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.

$100,000 - $130,000 a year - Part-time, Pulled from the full job description

• On-the-job training
• Health insurance
• Retirement plan
• Paid time off
• Paid holidays
• Flexible schedule, * 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: 100,000 - 130,000 USD per year(Minneapolis, MN)

Our client is a pioneering medical technology organization advancing MRI-compatible solutions for cardiac ablation procedures. Known for innovation in interventional MRI environments, the company develops cutting-edge platforms that help clinicians improve procedural precision, safety, and patient outcomes while transforming the future of electrophysiology.