Sr. Software Systems Engineer (Medical Devices)

Location: Fridley, Minnesota, United States of America

Salary: $120,800–$181,200 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies across global Neuroscience and other medical technology areas, with a focus on improving patient treatment and care.

What you will do

• Provide design quality support for software and software-enabled medical device programs from concept through transfer to manufacturing.
• Review system requirements, software requirements, architecture, design documentation, and development deliverables for completeness, traceability, and regulatory readiness.
• Support verification and validation strategies for software, system, and integration testing.
• Lead or support risk management activities, including hazard analysis, software risk evaluation, and mitigation verification.
• Partner with engineering, product development, regulatory, clinical, manufacturing, and quality teams to resolve design quality issues.
• Participate in design reviews, root cause analysis, corrective actions, mentoring, and continuous improvement of design quality processes.

Requirements

• Bachelor’s degree in software, computer, electrical, systems engineering, or a related technical field with at least 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, systems, design assurance, reliability, or quality engineering in a regulated industry.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.

Nice to have

• Experience in medical devices or another highly regulated environment.
• Knowledge of IEC 62304, ISO 14971, ISO 13485, FDA design control expectations, or related standards.
• Familiarity with agile development, software architecture reviews, cybersecurity, usability or human factors, and AI used in process development or embedded in products.
• Advanced degree in engineering or a related discipline.

Culture & Benefits

• Full-time employment with health, dental, and vision insurance for eligible regular employees.
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and incentive plans.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, and disability coverage.
• Tuition assistance, employee stock purchase plan, employee assistance program, and global well-being resources.