Kforce's client, a growing and established Medical Device company in San DIego, CA, is seeking a Mid-level and Senior Medical Device Software Design Quality Engineer. We are working directly with the Hiring Managers on these search assignments. This is a client we have worked with for many years. The company offers a competitive compensation including base salary, annual bonus, and Stock/RSUs Plan. This position is 100% remote. Responsibilities: * The Medical Device Software Quality Engineer will work with software teams, RA and NPD teams to ensure that the software projects are meeting regulations and quality standards * Take ownership of software projects for regulatory compliance and champion for process excellence by driving their teams towards conformance at every stage of development * Handle the Design Control process from beginning to end - will handle all 5 steps * Creates and reviews various software lifecycle project deliverables based on procedural requirements * Performs risk analysis and is responsible for risk management activities determines, evaluates, and documents software risks from product design to post-launch * Provides traceability analysis and traceability reports to ensure project requirements have been met * Participates on the Software Review Board (SRB) to evaluate and disposition software anomalies * Work with software teams, RA, NPD teams as well as other teams * As a Medical Device Software Quality Engineer, you will review and approve CO's as well as provides quality input to support closure (QMS updates, Procedural changes, etc.) * Provides quality input to Complaint, FA, CAPA investigations and executes corrective actions when applicable * Please note that this role will not be responsible for any software development or software testing; This is an FDA Medical Design Quality Engineering position