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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Software Quality Engineer - **Company:** SDI Inc - **Location:** United States - **Experience:** Expert - **Salary:** $200,000.0 - $270,000.0 - **Contract:** Permanent contract - **Skills:** Artificial Intelligence, Software Applications, Software System Penetration Testing, JIRA, Microsoft Azure, Software Bug Management, Software as a Service, Configuration Management, Software Quality, Cyber Security, Continuous Integration, DevOps, EHealth, Github, Graphics Software, Medical Software, Integrated Development Environments, Machine Learning, Release Management, Software Tools, Software Engineering, Verification and Validation (Software), Software Verification, 21 CFR Part 820 Quality System Regulation, Information Technology, Performance Monitor, Mdsap, Vulnerability Analysis - **Published:** October 6, 2026 - **Apply:** https://www.thejobnetwork.com/job/18f3b878-f57e-4792-902d-4627809cc8f7/principal-software-quality-engineer ## About the Role · Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Systems Engineering, or a related technical discipline. \n · Minimum of 8 years of experience in software quality engineering, software development, software verification and validation, quality engineering, or related medical device software role. \n · Minimum of 5 years of experience working in a regulated medical device, SaMD, digital health, diagnostic imaging, healthcare software, or other regulated life sciences environment. \n · Demonstrated knowledge of medical device design controls and software lifecycle requirements. \n · Demonstrated knowledge of the US FDA's expectations for maintaining AI/ML-enabled medical devices including predetermined change control plans, real-world performance monitoring, and algorithm change management. \n · Experience with software verification and validation, including review of test plans, protocols, test cases, test results, deviations, anomalies, and traceability. \n · Experience with risk management for medical devices, including hazard analysis, software risk analysis, cybersecurity risk analysis, and risk control verification. \n · Working knowledge of applicable standards and regulations, such as 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, and FDA guidance for medical device software. \n · Experience supporting software change control, release readiness, configuration management, and defect management. \n · Experience working with cross-functional teams, including software engineering, product, regulatory, clinical, cybersecurity, and quality. \n · Strong technical writing skills, including ability to write and review clear, complete, and audit-ready quality records. \n · Strong analytical and problem-solving skills, including ability to assess technical issues for quality, safety, cybersecurity, regulatory, and business impact. \n · Ability to work independently, prioritize work, and provide technical leadership in a fast-paced development environment. \n · Proficiency in English, including ability to read, write, review, and approve technical and quality documentation. \n Preferred qualifications include: \n · Master's degree in Software Engineering, Computer Science, Biomedical Engineering, Regulatory Science, Quality Assurance, or a related discipline. \n · Experience with AI/ML-enabled medical devices, imaging software, quantitative imaging biomarkers, radiology workflows, MRI image processing, or clinical decision-support software. \n · Experience with Class II SaMD regulatory submissions, including US FDA 510(k) submissions. \n · Experience with cloud-based software platforms and Microsoft Azure. \n · Experience with cybersecurity documentation for medical devices, including threat modeling, SBOM review, vulnerability assessment, penetration testing, and cybersecurity risk management. \n · Experience with automated testing frameworks, CI/CD pipelines, DevOps practices, GitHub, Jira, Azure DevOps, or similar tools. \n · Experience with software tool validation or computer software assurance. \n · Experience supporting US FDA inspections, ISO 13485 audits, MDSAP audits, supplier audits, or EU notified body audits. \n · ASQ Certified Software Quality Engineer, Certified Quality Engineer, Regulatory Affairs Certification, or similar professional certification. ## Description The Principal Software Quality Engineer is responsible for leading software quality assurance activities for our Class II AI/ML-based Software as a Medical Device (SaMD). This role provides technical leadership and quality oversight across the full software lifecycle, including design controls, risk management, verification and validation, cybersecurity, release management, post-market activities, change control, and quality system compliance., You will work closely with Software Engineering, Machine Learning, Product, Regulatory, Clinical, and Cybersecurity teams to ensure our software is developed, tested, released, maintained, and changed in a controlled, compliant, and risk-based manner that supports product safety, effectiveness, and quality, including Quality System requirements. You will also provide technical oversight, mentoring, and review of work performed by internal teams, consultants, contractors, and third-party service providers., The Principal Software Quality Engineer is responsible for supporting and leading software quality activities across the full product lifecycle, including design, development, verification, validation, release, maintenance, and post-market change control., · Oversee our cloud infrastructure (Azure/AWS), CI/CD pipelines, and DevSecOps practices.