This individual will provide end-to-end technical and operational leadership for the evaluation, selection, development, qualification, clinical implementation, and commercialization of devices used in the preparation and delivery of cell therapies, ensuring that the device, cell product, procedures, labeling, and user interface function safely and effectively as an integrated combination product. Lead or coordinate use-related risk analyses, formative and summative human factors studies, and usability evaluations for the complete combination product workflowSupport the development and execution of device verification and validation activities, including functional, performance, reliability, and compatibility testing.