Clinical Validation Specialist
Core
Senior clinical expert validating CT systems from an end-user perspective to ensure clinical satisfaction, regulatory compliance, and product design alignment.
Role type
Senior IC clinical validation specialist (medical imaging)
Builds
CT imaging systems for hospital diagnostic workflows
Domain
Medical imaging / Radiology / CT technology
Deliverable
production ML models | product features
Required skills
CT system operation and workflow expertise, clinical image quality assessment, regulatory compliance knowledge (FDA/NMPA/CE), defect management, cross-functional coordination, technical documentation in English
Preferred skills
Photon counting CT technology knowledge, AI tool application, radiologist or radiographer professional license, master's degree with thesis
Technologies
CT systems, defect management tools, QMS systems
Responsibilities
Define and execute design validation plans, protocols, and reports; coordinate site visits and clinical data collection; translate clinical feedback into defects; provide expert opinion on image quality and workflow to R&D; prepare validation evidence for regulatory bodies; lead internal and external audits as SME
Seniority
Senior, hands-on IC