Senior Manager - Clinical Validation

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 QMS compliance.
• Educational Qualifications:
• Bachelor's degree in Radiology & Imaging or related field.
• Minimum 15 years' experience in the medical imaging industry.
• Required Skills:
• Strong knowledge of multi-modality radiology workflows and systems.
• Experience in clinical validation, risk management, and QMS compliance.
• Excellent oral and written communication skills.
• Strong analytical and process-oriented mindset.
• Ability to work effectively in a collaborative, matrixed environment.
• Desired Characteristics
• Master's degree in Radiology & Imaging.
• Familiarity with clinical risk management
• Ability to lead diverse, cross-functional teams globally.
• Experience with SAFe Agile methodology.
• Understanding of user experience design and usability testing.
• Knowledge of AI/ML applications in imaging workflows.
• Strong leadership, negotiation, and stakeholder management skills.
• Inclusion and Diversity
• We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
• #EveryRoleIsVital
• #LI-SM1
• Additional Information
• Relocation Assistance Provided: Yes

Benefits

Additional Information

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

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