Kforce's client, a growing and established Medical Device Company is seeking a couple of Senior Software Design Quality Engineers in Costa Mesa, CA for a long-term position. We are working directly with the Hiring Manager on this search assignment. Responsibilities: * Medical Device Software Design Quality Engineer will work with software teams to ensure that the software projects are meeting regulations and quality standards * You will take ownership of software projects for regulatory compliance and champion for process excellence by driving their teams towards conformance at every stage of development * Will handle the Design Control process from beginning to end; Will handle the different 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 * Analyzes test results to ensure existing functionality and requirements are met, and if necessary, recommends corrective action * 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 * Will 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 SW Design Quality Engineering position