Senior Software Quality Engineer

Overview

Senior Software Quality & Design Assurance Engineer

Compensation: $100,500 - $150,675

Location:

Twin Cities

We re seeking an experienced Software Quality & Design Assurance Engineer to support end-to-end software quality activities across embedded systems, mobile apps, and cloud-based platforms. You ll ensure compliance with global medical device software standards, lead design assurance processes, and partner closely with engineering, regulatory, and product teams.

• Lead software quality and design assurance from concept through post-market
• Ensure compliance with FDA, ISO, and IEC software standards
• Manage software design control, traceability, V&V, and risk management
• Support documentation for regulatory submissions and cybersecurity requirements
• Oversee software change control and maintain audit-ready quality records
• Collaborate on secure design, threat modeling, and cybersecurity controls
• Provide training and guidance on software quality best practices

• Bachelor s in Engineering, Computer Science, or related field
• 5+ years of experience in medical device software quality
• Strong knowledge of 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971
• Experience with embedded software, mobile apps, and/or cloud platforms
• Skilled in documentation, testing methodologies, and cross-functional collaboration
• Bonus: ASQ CSQE, experience with document control systems, SBOM tools, or compliance platforms

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.