Principal Software Quality Engineer (New York)

About Us Surgeon Decision Intelligence (SDI) is an emerging leader in AI-driven medical imaging solutions for orthopedic care. Founded by a team of orthopedic spine surgeons and medical students from the Hospital for Special Surgery, the world’s best orthopedic hospital, our mission is to transform patient care by developing quantitative imaging biomarkers to inform treatment approaches for a broad spectrum of musculoskeletal disease and predict associated outcomes. We combine cutting-edge computer vision, medical image analysis, and machine learning to unlock new insights from MRI imaging, one of the most widely obtained modalities of medical imaging, accelerating the translation of novel imaging biomarkers from research into clinical practice. Our team is passionate about bridging the gap between advanced computational methods and real-world healthcare impact. Position Summary 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. Essential Responsibilities: 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. Essential responsibilities include, but are not limited to, the following: · Provide software quality engineering leadership for the Company’s Class II AI/ML-based Software as a Medical Device. · Support compliance with applicable medical device software regulations, standards, guidance documents, and internal quality system procedures. · Provide Quality oversight for software lifecycle activities, including requirements, design, development, verification, validation, release, maintenance, and change control. · Review and approve software quality documentation, including software requirements, design documentation, risk analyses, cybersecurity risk analyses, traceability matrices, verification protocols, validation protocols, test reports, release documentation, and change records. · Ensure software requirements are clear, testable, traceable, risk-based, and aligned with user needs and intended use. · Support design control activities, including design inputs, design outputs, design reviews, design verification, design validation, design transfer, and design changes. · Ensure appropriate traceability among requirements, design outputs, risk controls, verification testing, validation testing, defects, and released software. · Provide quality oversight for AI/ML-related software activities, including algorithm performance documentation, dataset considerations, acceptance criteria, validation activities, and change impact assessments. · Support software verification and validation activities, including test plans, test cases, automated testing, regression testing, performance testing, cybersecurity testing, deviations, anomalies, and final reports. · Evaluate software defects, deviations, and unresolved anomalies for safety, performance, cybersecurity, regulatory, and release impact. · Support software release readiness reviews and confirm required testing, documentation, risk assessments, cybersecurity activities, and approvals are complete. · Review and approve software change requests and impact assessments, including impact to requirements, risk management, cybersecurity, validation, labeling, and regulatory documentation. · Provide quality oversight for cloud-based software deployment, configuration management, access controls, release controls, CI/CD processes, source code repositories, and software development tools. · Support cybersecurity quality activities, including review of threat models, vulnerability assessments, penetration testing results, SBOM documentation, vulnerability dispositions, and cybersecurity risk mitigations. · Support supplier quality activities for software-related suppliers, cloud service providers, software development contractors, cybersecurity vendors, and other third-party service providers. · Support post-market software quality activities, including complaint investigations, CAPA, nonconformances, field issues, software patches, and maintenance releases. · Provide quality input for regulatory submissions and responses to regulatory questions related to software, cybersecurity, risk management, and verification and validation. · Participate in internal audits, external audits, supplier audits, and regulatory inspections related to software quality and SaMD development. · Identify and support improvements to software quality processes, design controls, risk management, verification and validation, cybersecurity, and release management. · Mentor cross-functional team members on software quality expectations, documentation practices, risk-based thinking, and medical device software compliance. · Oversee our cloud infrastructure (Azure/AWS), CI/CD pipelines, and DevSecOps practices. Minimum Qualifications: To be qualified for this role, the Principal Software Quality Engineer shall meet the following requirements: · Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Systems Engineering, or a related technical discipline. · Minimum of 8 years of experience in software quality engineering, software development, software verification and validation, quality engineering, or related medical device software role. · 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. · Demonstrated knowledge of medical device design controls and software lifecycle requirements. · 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. · Experience with software verification and validation, including review of test plans, protocols, test cases, test results, deviations, anomalies, and traceability. · Experience with risk management for medical devices, including hazard analysis, software risk analysis, cybersecurity risk analysis, and risk control verification. · 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. · Experience supporting software change control, release readiness, configuration management, and defect management. · Experience working with cross-functional teams, including software engineering, product, regulatory, clinical, cybersecurity, and quality. · Strong technical writing skills, including ability to write and review clear, complete, and audit-ready quality records. · Strong analytical and problem-solving skills, including ability to assess technical issues for quality, safety, cybersecurity, regulatory, and business impact. · Ability to work independently, prioritize work, and provide technical leadership in a fast-paced development environment. · Proficiency in English, including ability to read, write, review, and approve technical and quality documentation. Preferred qualifications include: · Master’s degree in Software Engineering, Computer Science, Biomedical Engineering, Regulatory Science, Quality Assurance, or a related discipline. · Experience with AI/ML-enabled medical devices, imaging software, quantitative imaging biomarkers, radiology workflows, MRI image processing, or clinical decision-support software. · Experience with Class II SaMD regulatory submissions, including US FDA 510(k) submissions. · Experience with cloud-based software platforms and Microsoft Azure. · Experience with cybersecurity documentation for medical devices, including threat modeling, SBOM review, vulnerability assessment, penetration testing, and cybersecurity risk management. Surgeon Decision Intelligence / TCS