Flexible Work, Better Balance
Position Summary
Sr. Software Design Controls Engineer thinks “outside the box” in the implementation of the Software Design Control and SDLC (software development lifecycle) programs at Caris Life Sciences, providing quality oversight, and ensuring compliance with all applicable regulations and incorporations of software industry best practices. The position will work in collaboration with the Software Development, Bioinformatics, IT, Information Security (InfoSec), Regulatory Affairs, project/program management, and other cross-functional teams throughout the SDLC.
Job Responsibilities
Supports the implementation of the SDLC and software design controls as per the requirements of ISO 13485/FDA QSR design controls and IEC 62304.
Participates in process improvement of software design controls and other impacted SDLC processes, work instructions and templates. This includes the ability to perform gap analysis, impact ...