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    Senior Manufacturing Engineer, Instruments - Los Angeles, United States - CytoVale

    CytoVale
    CytoVale Los Angeles, United States

    3 weeks ago

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    Description


    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 launch
    Proactively identify and lead throughput expansion projects necessary to fulfill forecasts
    Support/lead technical projects to improve Quality and reduce Cost
    Lead/manage design change deliverables associated with establishing reliable MFG processes & risk management
    Partner with R&D and CM with New Product Introduction (NPI) projects
    Support MFG non-conformance root cause analysis investigations and mitigations
    Partner with internal QA and CMs to establish/maintain effective component incoming QC inspection, in-line process validations & monitoring, and lot release testing
    Partner with R&D ENG in support of product lifecycle management (PLM) including developing, implementing DFM opportunities, continuous improvement, and mitigating component supply chain issues
    Support/lead projects to qualify additional/alternative suppliers as necessary
    Occasional domestic travel (~25%)


    Minimum Qualifications:
    BS degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related Engineering field
    5 years of experience in product/process development in Medical Device industry
    Effective experience managing contract manufacturer/supplier
    Effective experience with developing product specifications, MFG Work Instructions, MFG
    Deviations, Non-Conformance Reports, CAPAs
    Effective experience with Risk Management (pFMEA); Process controls & monitoring, and Validation
    Effective experience with Computer Aided Design (Solidworks)
    Effective at critical thinking and managing complex projects
    Good organizational skills as well as strong written/verbal communications skills that could be used successfully in negotiation, influence, and conflict management
    The ability to prioritize tasks, drive process improvements and thrive in a fast-paced environment


    Preferred Qualifications:
    Experience developing/manufacturing capital systems; IVD preferred
    Experience scaling-up MFG
    Principles of Design For Manufacturability (DFM)

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