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    Process Engineer - Buffalo Grove, United States - Nemera

    Nemera
    Nemera Buffalo Grove, United States

    2 weeks ago

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    Description
    Job Description

    This is a "hands on" engineering position responsible for leading the development, installation, validation, ramp-up, and life cycle management of injection molds and molding solutions for medical device components.

    Responsibilities:
    • Serve as a Subject Matter Expert (SME) for injection molding systems.
    • Develop a robust and repeatable process window based on scientific process engineering principles.
    • Implement statistical process analysis on new and existing molds
    • Document all injection molding system set-up requirements in Process Information Books and one-point lessons.
    • Trouble shoot process related issues through a structured DOE
    • Support the development of new injection molds by participating in mold design reviews and mold factory acceptance trials.
    • Support the production ramp-up phase for new products and train appropriate personnel as needed.
    • Lead Factory Acceptance Testing (FAT) at domestic and European mold vendors.
    • Track process performance metrics and manage ramp-up action plan to achieve operational performance targets.
    • Manage multiple programs with continuous collaboration with the project teams.
    • Investigate and benchmark new tooling, peripherals, and molding technologies.
    • Contribute to the development of specifications for the procurement of new injection molding machines and auxiliaries.
    • Perform the initial set-up and establish the standards for injection molding systems.
    • Implement safety, productivity, and yield improvements
    • Provide continuous development of manufacturing techniques that will improve in-house capabilities.
    • Participate with root cause investigations and corrective action implementation.
    • Support lean and continuous improvement initiatives.
    • Follow all safety procedures including the use of Personal Protective Equipment as required.
    • Maintain good housekeeping of both office and factory workspaces.
    • Work in ISO7 and ISO8 controlled environments with cGMP gowning requirements.
    Preferred/Required Education/Skills:
    • Engineering, technical degree or equivalent
    • RJG Master Molder I Certification strongly preferred
    • Process Engineering experience working in high-volume plastic injection molding
    • Industrial manufacturing experience working in high-volume injection molding
    • Experience in the qualification of complex, tight tolerance injection molds (2-shot + Cube mold technologies)
    • Must have clear and well organized oral and written communication
    • Knowledge of statistical methods (6 Sigma, SPC, DoE)
    • Excellent problem solving skills using DMAIC methodology
    • Experience working in a cGMP / ISO 13485 compliant manufacturing environment
    • Occasional travel up to 15 percent based on assignments; domestic and international
    • Ability to lift 55lbs
    ADDITIONAL NOTES

    This Job Description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee and may be revised at any time by the Company.

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