This key role partners with our Contract Manufacturers (CMs) to ensure Supply, Quality, and Cost targets are achieved for successful clinical operations, and commercialization.As the Senior Manufacturing Engineer, you will be a key member of the Operations team. You will represent Cytovale with our Contract Manufacturers (CMs) as both the customer and as the technical partner to facilitate Capacity, Quality, and Cost projects as we prepare for initial product launch. Span of responsibilities includes supporting Design Control activities, preparations for commercial launch, partner with R&D to implement product lifecycle management of the Cytovale in vitro diagnostic (IVD) system, product testing, troubleshooting, root cause analysis, and implementing process control solutions for the Cytovale in vitro diagnostic (IVD) system.Activities may be a blend of strategic supplier development projects, scale-up, implementing Design for Manufacturability (DFM) improvements, and partnering with supplier(s) to realize opportunities for scale and efficiencies.This position requires to be on-site in the San Francisco office 4-5 days a week.Primary Responsibilities:Represent Cytovale as a key technical point of contact for our Contract Manufacturer(s) as we prepare for initial commercial launchProactively identify and lead throughput expansion projects necessary to fulfill forecastsSupport/lead technical projects to improve Quality and reduce CostLead/manage design change deliverables associated with establishing reliable MFG processes & risk managementPartner with R&D and CM with New Product Introduction (NPI) projectsSupport MFG non-conformance root cause analysis investigations and mitigationsPartner with internal QA and CMs to establish/maintain effective component incoming QC inspection, in-line process validations & monitoring, and lot release testingPartner with R&D ENG in support of product lifecycle management (PLM) including developing, implementing DFM opportunities, continuous improvement, and mitigating component supply chain issuesSupport/lead projects to qualify additional/alternative suppliers as necessaryOccasional domestic travel (~25%)Minimum Qualifications:BS degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related Engineering field5 years of experience in product/process development in Medical Device industryEffective experience managing contract manufacturer/supplierEffective experience with developing product specifications, MFG Work Instructions, MFGDeviations, Non-Conformance Reports, CAPAsEffective experience with Risk Management (pFMEA); Process controls & monitoring, and ValidationEffective experience with Computer Aided Design (Solidworks)Effective at critical thinking and managing complex projectsGood organizational skills as well as strong written/verbal communications skills that could be used successfully in negotiation, influence, and conflict managementThe ability to prioritize tasks, drive process improvements and thrive in a fast-paced environmentPreferred Qualifications:Experience developing/manufacturing capital systems; IVD preferredExperience scaling-up MFGPrinciples of Design For Manufacturability (DFM)#J-18808-Ljbffr

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