Senior Software Systems Engineer (Medical Devices)

Location: Fridley, Minnesota, United States

Salary: $120,800–$181,200 per year, plus eligibility for a short-term incentive plan.

Company

Healthcare technology organization developing medical devices and technologies for neurological, spinal, and pelvic health conditions.

What you will do

• Provide design quality support for software and software-enabled medical device programs from concept through transfer to manufacturing.
• Ensure compliance with design control, software lifecycle, risk management, and regulatory requirements.
• Review system and software requirements, architecture, design documentation, and development deliverables for completeness and traceability.
• Support verification and validation strategies for software, system, and integration testing.
• Partner with engineering, product development, regulatory, clinical, manufacturing, and quality teams to resolve design quality issues.
• Support hazard analysis, risk mitigation verification, design reviews, root cause analysis, corrective actions, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in software, computer, electrical, systems engineering, or a related technical field with 4+ years of relevant experience; alternatively, a master’s degree with 2+ years or a PhD with no required experience.
• Experience with design controls, software development lifecycle activities, and verification and validation.
• Strong understanding of risk management, design failure analysis, and traceability across requirements, design, and testing.
• Experience supporting cross-functional product development teams.
• Experience in software engineering, systems engineering, design assurance, reliability, or quality engineering within a regulated industry is preferred.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment; sponsorship is offered only for Principal-level roles and above.

Nice to have

• Knowledge of IEC 62304, ISO 14971, ISO 13485, FDA design control expectations, and related standards.
• Familiarity with agile development and integrating quality practices into iterative workflows.
• Experience with AI in process development or embedded products.
• Experience with software architecture reviews, cybersecurity considerations, usability, or human factors.
• Advanced engineering degree and strong written and verbal communication skills.

Culture & Benefits

• Full-time employment within a global healthcare technology organization.
• Health, dental, and vision insurance, plus health and dependent-care spending accounts.
• Life insurance, disability coverage, paid time off, and paid holidays.
• 401(k) plan with employer contribution and match, incentive plans, and employee stock purchase plan.
• Tuition assistance or reimbursement and a global well-being program.