Senior Manager - Clinical Validation

GE HealthCare — IND19-01-Bengaluru-EPIP 122 (Phase II)

Job Description Summary The Clinical Validation Manager will lead a team of Imaging Technologists and Radiologists to validate SEI products from a clinical perspective, ensuring compliance with established processes and regulatory standards. This role requires strong radiology domain expertise across multiple modalities, a solid foundation in functional skills, and knowledge of relevant technologies. The manager will coordinate cross-functional teams to define and realize a modern user experience within SEI, focusing on optimal workflows, user-centered design principles, and customer needs. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world Job Description Key Responsibilities: Lead clinical validation activities for SEI products, ensuring adherence to regulatory and QMS requirements Develop and maintain clinical validation protocols, test cases, and documentation aligned with product requirements. Ensure traceability between clinical requirements, validation results, and regulatory compliance. Collaborate with engineering and product teams to translate clinical and user requirements into actionable deliverables within Agile/Scrum frameworks. Engage early in the development cycle to provide clinical feedback and risk assessments. Validate SEI products from an end-user perspective within defined timelines. Work directly with end users to capture workflow challenges and incorporate insights into product design. Assess modern analytics and AI/ML technologies for clinical applicability. Coordinate usability testing and clinical risk analysis with UX and product management teams. Provide clinical education and guidance to global engineering teams. Drive continuous improvement in validation processes and

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