Sr. Process Development Engineer

Title : Sr. Process Development EngineerLocation : Bay Area CA ON-SITE Role Job Responsibilities:You will participate in or lead Equipment and Process Development, Process Characterization and Process Qualification to support new product introduction. You will utilize functional excellence in process development including DFM, process characterization, equipment development, Lean and Six Sigma methodologies. You will drive results on project teams, through building relationships and strong technical decision making.Partner with Design Engineering to identify Design for Manufacturability and Assembly targetsPartner with purchasing to ensure all needed materials procurement per process development/validation/training needs and the 1st year forecastPlan and coordinate the execution of process characterization and validationSuccessfully complete all the Process Development Engineering elements of the PDP by the milestone datesPartner with production to ensure all LMR builds and first 3 months of commercial builds completed on timeCreate all required documents (manufacturing processes, protocols, reports, etc.)Ensure process capability and yield targets are metProvide mentoring and direction to more junior technical staffHands-on development of manufacturing processesDesign, Develop and qualify (IQ) tooling / equipment Develop and qualify in-process test methods (TMV, test method validation)Present status of plans and projects to larger team • Develop requirements and procure equipment for manufacturing processesLead small team(s) for process development or problem solvingQualification Requirements:Bachelor’s degree in an engineering/technical discipline requiredMinimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years relevant experienceSkills: Demonstrated problem solving leadership skills (A3 DMAIC, first principles, and DOE)History of successfully transferring projects to manufacturingGreen Belt or Black Belt training/certification; Minitab skills (normality, capability, hypothesis test, DOE, gage R&R, etc.)Medical device catheter manufacturing experienceExperience with polymer extrusion, reflow, thermal bonding, and adhesive bondingProcess error proofing (poka-yoke) experience Fixture design and developmentExperience meeting time-bound objectives Demonstrated project planning and executionGood presentation skillsLeadership and self-starter qualitiesPre-requisites / Job Experience:Experience developing and validating medical device manufacturing processes (IQ, OQ, PQ, and PPQ)Working knowledge of PFMECAs, sampling plans, normality assessment, and capability assessmentProcess validation protocol and report writingClass II or III medical device manufacturing experience