Software Quality Assurance Engineer - Medical Devices

We’re seeking an experienced Senior Software Quality Assurance Engineer to provide independent Quality oversight and advanced technical guidance for the development, validation, release, and post-market maintenance of software-based medical devices.

This role independently leads complex Software Quality activities within established Quality System and software lifecycle frameworks, including the review of software requirements, testing strategies, cybersecurity controls, and validation, while supporting continuous improvement.

You’ll partner closely with Software Development, Product Development, Regulatory Affairs, Manufacturing, and Product Management to ensure products are safe, effective, secure, and compliant with applicable regulatory and Quality requirements., This position provides leadership and Quality oversight across:

• Software Quality & Design Control Oversight
• Technical Software Review
• Verification & Validation
• Software Risk Management
• Cybersecurity Quality Oversight
• Quality System & Compliance
• Supplier Quality & Third-Party Software Oversight

• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, Computer Engineering, or a related technical discipline
• Minimum 5 years of progressive experience in Software Quality Assurance, Software Engineering, Software Validation, or Software Quality Engineering within a regulated industry, including demonstrated experience independently leading complex Software Quality activities in a regulated environment
• Hands-on software development experience with the ability to independently evaluate software engineering deliverables
• Experience with one or more programming languages, including C++, and embedded software development
• Ability to assess software development best practices
• Understanding of software build and release processes
• Knowledge of APIs, cloud services, and system integrations
• Experience with Azure DevOps, GitHub, GitLab, Jira, Jama, automated testing frameworks, and Continuous Integration/Continuous Deployment (CI/CD) environments

REGULATORY & QUALITY KNOWLEDGE: Working knowledge of:

• FDA 21 CFR Part 820
• FDA Design Controls
• FDA Software Validation Guidance
• FDA Cybersecurity Guidance
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 60601
• IEC 81001-5-1
• ISO/IEC 27001
• EU MDR
• MDSAP requirements
• Applicable global medical device regulations and standards, * Medical device industry experience
• Experience with Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), embedded software, connected medical devices, mobile applications, cloud-based software platforms, and/or AI-enabled technologies
• Ability to read and understand source code and experience participating in code reviews
• Understanding of software architecture and design patterns
• Experience participating in regulatory inspections and Quality System audits
• ASQ Certified Software Quality Engineer (CSQE)
• ISTQB Software Testing Certification
• Certified Secure Software Lifecycle Professional (CSSLP)
• Certified Information Systems Security Professional (CISSP)
• ISO/IEC 27001 Internal Auditor or Lead Auditor

READY TO MAKE AN IMPACT?

• If you bring strong Software Quality expertise, hands-on software development knowledge, and experience working in a highly regulated environment, we’d like to hear from you.