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    Head of Manufacturing Engineering - Indiana, United States - Catalyst Life Sciences

    Catalyst Life Sciences
    Catalyst Life Sciences Indiana, United States

    2 days ago

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    Description

    The client is seeking a Head of Manufacturing Engineering r to take on the responsibility for managing a team of engineers who provide technical support for on-going plant manufacturing operations in the tissue tech Skin product and Medical Product areas.

    Responsibilities:

    • Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with procedures and statutory requirements (US FDA and ISO)
    • Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device manufacturing
    • Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing

    Qualifications:

    • 8+ years experience in the medical device or pharmaceutical industry
    • Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines is required
    • Experience managing direct reports (REQUIRED)

    For more information about this or other positions please contact Colby Cahill at or

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