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    Manufacturing Engineer - Raynham, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Raynham, United States

    1 week ago

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    Description
    Responsibilities:

    2-5 years of experience in manufacturing and/or process engineering.

    Development of specifications and user requirements for new equipment that supports manufacturing operations

    Planning, development, and execution of equipment/process qualifications as it relates to CNC machining, manufacturing, inspection, and production readiness

    Support development of and author Process Validation/Verification/ Qualification documents, Work Instructions, Manufacturing Specifications, and Standard Operation Procedures, etc.

    Perform statistical analysis of data to determine process capability

    Assess, review, and support the development of product inspection Test Methods and Test Method Validations (TMV's)

    Support cross functional teams working on equipment/facility commissioning and qualification

    Takes ownership of validation/verification deliverables throughout execution of Project

    Ensures technical deliverables are completed to schedule

    May require international travel (up to 10%)

    Experience working in a regulated industry, such as Medical Device, Pharma or Biotech.

    Experience with CMM (Coordinate Measuring Machine) equipment.

    Experience in project management.

    Experience with machining processes, metal finishing processes, laser processing or production automation.

    Knowledge of statistical data analysis and associated tools (e.g. Minitab).


    Supports the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost.

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