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    Validation Engineer - Arlington, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Arlington, United States

    2 weeks ago

    Default job background
    Description
    Responsibilities:
    • Develop Standard Work for all injection molding processes and support activities and help train leaders in each functional area.
    • Establish and maintain internal specifications and process documentation for injection molding processes and tooling ensuring processes and procedures are clearly stated and understandable for all employees
    • Work closely with Product Development and Manufacturing to incorporate Design for Manufacturing (DFM) principals into all injection molded parts and assemblies
    • Justify and generate capital expense proposals and manage capital projects for new machinery, automation and tooling
    • Resolve technical tooling and process problems associated with both new and existing tooling. Hands-on technical resource for shop floor support when necessary
    • Monitor and report issues with injection molds; make recommendations for refurbishment based on production factors such as cycles, process capability, and tooling history
    • Validation Protocol & Report support. Preparation of validation samples as required;
    • Create, support, and/or execute Installation Qualification ("IQ")/Operational Qualification ("OQ")/ Performance Qualification ("PQ");
    • Support creation of Process Failure Mode Effects Analyses ("PFMEAs") and process control plans;
    • Support Design Transfer Agreement Plan (DTAP), Process Assessment Tool, & Design Transfer Checklist. (6) Assist & Support New Product Introduction Quality Engineers ("NPI QE") with other NPI deliverables as requested;
    • Creation/Release of validation/documentation in Valgenesis & OnePLM
    • Bachelor's degree preferably Manufacturing, Industrial Engineering

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