Principle Software Quality and Test Engineer, Medical Imaging

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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/

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