Principle Software Quality and Test Engineer, Medical Imaging

We’re on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you. Apart from job satisfaction, we can offer you: HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance - Life Insurance - Critical illness cover WEALTH: - Salary structure and Flexi basket - Provident fund of 12% - Gratuity scheme YOURSELF: Internal growth and development programs & trainings Job Summary: As Principle Software Quality and Test Engineer, Medical Imaging, you will lead the planning, implementation, and continuous improvement of software quality engineering practices to ensure that all software developed for regulated life sciences products complies with applicable standards (e.g., FDA 21 CFR Part 11, ISO 13485, IEC 62304) and delivers safe, effective, and reliable performance. In this role, you must understand the project technically & functionally and implement the test approach defined in the test plan documents. You must also understand the system validation activities, functional and technical aspects of the work and implement the test approach defined with an understanding of how it changes throughout the software development lifecycle (SDLC) Key Accountabilities Quality Architecture &Test Strategy Design and implement comprehensive quality architectures for multi-tenant SaaS medical imaging platforms Architect scalable test automation frameworks optimized for medical imaging workflows and AI/ML validation as requested. Establish quality gates and testing strategies across microservices-based systems · Design API testing strategies for seamless integration with clinical trial systems · Develop comprehensive test strategies that scale across multiple concurrent clinical trials and imaging workflows. AI/ML Testing & Validation Lead the design and implementation of testing frameworks for AI/ML models in medical image analysis, including genAI, agentic AI, computer vision, and deep learning algorithms Design and implement validation strategies for real-time and batch processing of medical imaging data (DICOM, NIfTI, etc.) Develop comprehensive test approaches for DICOM-compliant data processing pipelines Architect performance and accuracy testing for DICOM image preprocessing workflows Design monitoring and validation frameworks for AI models in production environments · Implement data quality validation for AI training and inference pipelines Medical Imaging Test Infrastructure Architect and implement comprehensive testing solutions for third-party medical imaging viewer integrations (OHIF, Cornerstone.js, or proprietary systems) Design and implement automated testing for APIs and SDKs integrated with clinical trial management systems Develop test frameworks for real-time collaboration features across multi-site clinical trials Create automated validation for AI-generated insights and annotations · Ensure test coverage for cross-platform compatibility across various devices and browsers Design test data management strategies for medical imaging workflows Regulatory Compliance & Security Testing Design and implement comprehensive test strategies for FDA 21 CFR Part 11, GxP, HIPAA, GDPR, and international medical device regulations compliance Architect automated validation frameworks for audit trails, electronic signatures, and data integrity controls Design security testing frameworks including encryption validation, role-based access control testing, and authentication/authorization verification Develop disaster recovery and business continuity testing strategies for critical clinical trial data Ensure test coverage for medical data privacy regulations across multiple jurisdiction Lead CSV (Computer System Validation) activities and maintain validation documentation Database & Data Quality Testing Design comprehensive test strategies for medical imaging metadata and AI model output validation Implement automated testing for large-scale medical imaging data storage, retrieval, and processing Design data integrity and consistency testing across multi-dimensional medical data Architect performance testing for real-time data streaming in live imaging analysis Implement data quality validation frameworks and lineage tracking verification Performance & Scale Testing Design and implement comprehensive performance testing frameworks for SaaS platform scalability Architect load and stress testing strategies for large medical imaging file processing and secure transfer Implement performance validation for caching strategies and CDN solutions across global clinical trial sites Design SLA validation frameworks and automated performance regression testing Establish performance benchmarks and monitoring for platform reliability Test Automation & DevOps Lead the design and implementation of modern test automation frameworks and CI/CD pipeline integration Architect test infrastructure using containerization and serverless technologies Implement shift-left testing practices and test-driven development methodologies Design and implement continuous testing strategies for automated deployment pipelines Establish test observability and reporting frameworks Implement infrastructure-as-code for test environments Technical Leadership Engage in technical decisions on test tooling and quality engineering technology stack selection, in collaboration with Solution Architect and development teams Mentor team members to foster their professional, technical, and domain growth in quality engineering Establish and enforce test standards, quality processes, and best practices via code reviews, inspection, and discussion Lead technical architecture reviews for test infrastructure and provide guidance on complex quality engineering decisions Lead by example, demonstrating strong technical leadership skills and fostering a collaborative and innovative quality culture Drive adoption of quality metrics and KPIs across development teams Quality Leadership Lead cross-functional quality initiatives across product development teams, ensuring software risks are identified, mitigated, and resolved early in the lifecycle. Supports Audits: Prepare and present software quality documentation for internal and external audits ensuring audit readiness and compliance Innovation & Continuous Improvement Drive adoption of emerging technologies in test automation, AI/ML testing, and quality engineering tools Monitor the market to gather intelligence on emerging quality engineering practices and tools Lead initiatives to modernize quality engineering practices while maintaining regulatory compliance Share knowledge and insights through presentations, documentation, and training sessions Promote innovation in validated environment testing approaches Other Carryout any other reasonable duties as requested. Functional Competencies (Technical Knowledge/Skills) Solid understanding of DICOM standard implementation and testing requirements, including DICOM conformance statement validation and IHE integration profile testing Advanced knowledge and experience of testing medical imaging modalities (CT, MRI, X-Ray, PET, Ultrasound) and their specific 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 Experience in DICOMweb services validation Experience in security testing frameworks, encryption validation, and identity management testing Advanced knowledge of test data management for medical imaging workflows Expertise in performance testing tools and methodologies for cloud-native applications Working knowledge of cloud platforms and basic AI/ML services Strong understanding of risk-based testing approaches in regulated environments Excellent technical leadership and mentoring capabilities in quality engineering Strong stakeholder management skills with ability to communicate complex quality concepts to product, development, and business teams Experience leading cross-functional quality initiatives in regulated environments Proven ability to balance quality excellence with business objectives and regulatory requirements Behavior Competencies Accountability Adaptability Customer focus Robust Decision Making Business Acumen Results orientation Time Management Willingness to learn Team collaboration Attention to detail Critical thinking Problem-solving Experience, Education and Certifications 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 with strong understanding of serverless and scalable architecture validation, modern cloud-native service testing, and AI/ML service validation Extensive experience with DICOM image processing testing, anonymization validation, and metadata integrity verification Experience with medical image viewer testing, PACS integration validation, and DICOM routing workflow verification Advanced experience with medical imaging standards testing (DICOM, HL7 FHIR) Extensive experience with DICOM standard validation, including DICOM parsing verification, tag manipulation testing, and compliance validation 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, preferably in medical imaging 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 Experience with modern frontend testing frameworks for medical imaging applications (Selenium, Cypress, Playwright) 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 Experience with test observability and reporting tools Experience with performance testing tools Experience with security testing tools and methodologies ISTQB Advanced or Expert level certification preferred Bachelor's Degree (Master's or PhD preferred) in Computer Science, Biomedical Engineering, Software Engineering, or related technical discipline Additional certifications in cloud platforms preferred Medical device software validation training or certification preferred Certified Software Quality Analyst (CSQA) or similar quality certifications preferred English: Fluent Come as you are. We're proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.