Sr. Software Systems Engineer - Premarket Design Quality (Medical Devices)

Location: Fridley, Minnesota, United States of America. Candidates below Principal level must possess unrestricted U.S. work authorization at hire and throughout employment; U.S. sponsorship is not available for this role.

Salary: $120,800–$181,200 USD annually for U.S. locations excluding Puerto Rico and certain California locations.

Company

hirify.global develops healthcare technologies across more than 150 countries, serving patients through its global Neuroscience and other medical technology organizations.

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 controls, software lifecycle requirements, risk management practices, and applicable regulatory expectations.
• Review system and software requirements, architecture, design documentation, and development deliverables for completeness, traceability, and readiness.
• Support verification and validation strategies for software, system, and integration testing.
• Lead software risk evaluation and mitigation verification, including hazard analysis, and participate in design reviews.
• Partner with engineering, product development, regulatory, clinical, manufacturing, and quality teams; support root cause analysis, corrective actions, continuous improvement, and mentoring.

Requirements

• Bachelor’s degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field with at least 4 years of relevant experience; or a master’s degree with at least 2 years; or a PhD with 0 years of relevant 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.
• For a bachelor’s degree earned outside the United States, the degree must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Experience in software engineering, systems engineering, design assurance, reliability, or quality engineering in a regulated industry.
• Medical device or other highly regulated industry experience.
• 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 development.
• Experience using AI in process development or embedded in products.
• Experience with software architecture reviews, cybersecurity, usability, or human factors.
• Strong written and verbal communication, collaboration and influence skills; ability to manage multiple priorities.
• Advanced degree in engineering or a related discipline.

Culture & Benefits

• Full-time regular employment within a global healthcare technology organization.
• Benefits for eligible regular employees include health, dental and vision insurance, HSA/FSA, life insurance, disability coverage, paid time off, paid holidays, and retirement plans.
• Additional benefits include tuition assistance, dependent daycare spending account, employee stock purchase plan, employee assistance program, and a global well-being program.
• Eligible for the hirify.global Incentive Plan and other incentive programs.

Hiring process

• Applications are expected to close on 11 November 2026.
• Applications must be submitted through official hirify.global channels; legitimate recruiting communications use approved hirify.global platforms and official @hirify.global.com addresses.