Principle Software Quality and Test Engineer, Medical Imaging

Overview

Lead the planning, implementation and continuous improvement of software quality engineering for regulated life sciences products, ensuring compliance with applicable standards (FDA 21 CFR Part 11, ISO 13485, IEC 62304) and reliable performance of medical imaging software.

What you'll do

• Design and implement quality architectures and test automation frameworks for multi-tenant SaaS medical imaging platforms.
• Design testing frameworks for AI/ML models in medical image analysis, including validation of real-time and batch processing of DICOM and NIfTI data.
• Architect testing for third-party medical imaging viewer integrations (such as OHIF, Cornerstone.js, or proprietary systems) and for APIs and SDKs integrated with clinical trial management systems.
• Design comprehensive test strategies for FDA 21 CFR Part 11, GxP, HIPAA, GDPR and international medical device regulation compliance.
• Architect automated validation for audit trails, electronic signatures and data integrity controls, and design security testing (encryption, role-based access control, authentication and authorization).
• Develop disaster recovery and business continuity testing strategies for critical clinical trial data.
• Lead Computer System Validation (CSV) activities and maintain validation documentation.
• Design test strategies for medical imaging metadata, AI model output validation, data integrity and performance and scale testing.
• Design SLA validation frameworks, performance regression testing and load and stress testing for large medical imaging file processing.
• Lead test automation and CI/CD pipeline integration, including containerized and serverless test infrastructure, shift-left testing and infrastructure-as-code for test environments.
• Engage in technical decisions on test tooling and technology stack, mentor team members, establish test standards and lead architecture reviews.
• Lead cross-functional quality initiatives, identify and mitigate software risks early, and prepare quality documentation for internal and external audits.
• Drive adoption of emerging technologies in test automation, AI/ML testing and quality engineering, and share knowledge through presentations, documentation and training.
• Carry out any other reasonable duties as requested.

What you'll need

• Solid understanding of DICOM standard implementation and testing, including DICOM conformance statement validation and IHE integration profile testing.
• Advanced knowledge and experience testing medical imaging modalities (CT, MRI, X-Ray, PET, Ultrasound) and their DICOM implementations.
• Expertise in designing test automation frameworks for message queuing systems and high-throughput medical data processing.
• Deep knowledge of clinical trial processes, regulatory requirements (FDA 21 CFR Part 11, GxP, HIPAA, GDPR) and quality management systems (ISO 13485, IEC 62304).
• Expertise in AI/ML testing methodologies for medical imaging (computer-aided diagnosis, image segmentation, model validation).
• Proficiency in containerization, serverless architectures and cloud-native testing strategies.
• Advanced knowledge of API testing and real-time communication protocol validation, and experience with DICOMweb services validation.
• Experience in security testing frameworks, encryption validation and identity management testing.
• Advanced knowledge of test data management for medical imaging workflows and expertise in performance testing tools for cloud-native applications.
• Working knowledge of cloud platforms and basic AI/ML services; strong understanding of risk-based testing in regulated environments.
• Excellent technical leadership and mentoring capabilities; strong stakeholder management and ability to communicate complex quality concepts.
• Experience leading cross-functional quality initiatives in regulated environments; proven ability to balance quality excellence with business objectives and regulatory requirements.
• Deep and wide-ranging post-qualification software quality engineering and test automation expertise, with leadership in complex projects involving medical imaging or healthcare technology.
• Deep expertise in cloud platform testing, including serverless and scalable architecture validation, cloud-native service testing and AI/ML service validation.
• Extensive experience with DICOM image processing testing, anonymization validation, metadata integrity verification, DICOM parsing verification, tag manipulation testing and compliance validation.
• Experience with medical image viewer testing, PACS integration validation and DICOM routing workflow verification.
• Advanced experience with medical imaging standards testing (DICOM, HL7 FHIR).
• Expertise in database testing for both relational and NoSQL systems.
• Proven experience designing and implementing quality engineering strategies for cloud-native SaaS platforms at enterprise scale.
• Demonstrated experience with AI/ML testing and validation in production environments.
• Deep experience with regulated software validation (FDA, GxP, ISO 13485, IEC 62304) and CSV processes.
• Strong background in medical imaging file format testing, processing library validation and viewer integration testing.
• Experience with clinical trial management system testing and electronic data capture (EDC) platform validation.
• Advanced proficiency in Python, Java or C# for test automation development.
• Hands-on experience with cloud service testing (compute, storage, databases, AI/ML services and monitoring validation).
• Extensive experience with CI/CD pipeline integration, infrastructure-as-code testing and DevOps practices, plus test observability and reporting tools.
• Experience with performance testing tools and security testing tools and methodologies.
• Bachelor's degree in Computer Science, Biomedical Engineering, Software Engineering or a related technical discipline.
• English: fluent.

Nice to have

• ISTQB Advanced or Expert level certification.
• Master's or PhD in Computer Science, Biomedical Engineering, Software Engineering or a related technical discipline.
• Additional certifications in cloud platforms.
• Medical device software validation training or certification.
• Certified Software Quality Analyst (CSQA) or similar quality certification.
• Experience with modern frontend testing frameworks for medical imaging applications (Selenium, Cypress, Playwright).