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    Senior Packaging Engineer - Bloomington, United States - Cook Group

    Cook Group
    Cook Group Bloomington, United States

    2 weeks ago

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    Description

    Overview:

    The Senior Packaging Engineer procures and develops packaging for new and existing products. This individual leads packaging activities with a cross-functional team including SBU Product Management, Regulatory Affairs, Operations, Quality Assurance, Clinical Affairs, and other personnel, including New Product and Sustaining Engineering. Direct interaction with the Global Sterilization group in the review, planning and execution of packaging efforts for current and potential sterilization modalities. Deeply connected and involved in all aspects of the Global Sterilization Corporate Program (GSCP) and in development of global packaging processes.

    Responsibilities:

    Member of Global Sterilization Corporate Program (GSCP)

    Develop global packaging processes and libraries

    Work directly on global new product development

    Apply packaging design principles from the pharmaceutical/medical device field to maintain and develop appropriate packaging solutions
    Develop and maintain department standards in packaging. Inclusive of environmental and regulatory standards related to medical packaging design and test (e.g., ASTAM F1886, F88, F2096, D4169 and ISO
    Ability to lead multiple projects to successful completion with tight timelines and critical deliverables
    Ensure compliance of equipment and packaging designs with company quality system
    Perform verification and validation testing of packaging designs and manufacturing methods
    Write and maintain appropriate documentation per the company quality system
    Evaluate issues with existing packaging and implement corrective actions

    Work with appropriate suppliers to implement packaging and package handling systems, including material and equipment selection, for new and existing products

    Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
    Must strictly adhere to safety requirements
    Maintain regular and punctual attendance
    Must maintain company quality and quantity standards
    Must have effective oral and written communications throughout various levels of the global organization
    Ability to work in collaborative and independent work situations and environments with minimal supervision
    Ability to remain calm and receptive in fast paced situations

    Qualifications:

    Master of Science in Packaging Science, or closely related field; or Bachelor's degree in Mechanical Engineering, Packaging Science or closely related field and 5 years experience; or experience of such kind and amount as to provide a comparable background

    Product and packaging stability and/or accelerated aging testing a plus

    Experience with medical packaging materials (Tyvek, PE/PET films, PETG trays, etc.)

    Experience with environmental and regulatory requirements and standards that relate to medical packaging design and testing (i.e. ASTM F1886, F88, F2096, D4169, and ISO

    A problem-solving approach with application of root cause analysis and failure mode methodology

    Ability to work with, interpret and apply packaging engineering drawings and specifications. Solid modeling design a plus

    Experience in developing and applying and fulfilling design inputs requirements for packaging

    Physical Requirements:

    Works under general office environmental conditions

    Works with manufacturing teams on continuous improvement processes in the manufacturing environments

    Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.

    Research and designs using standard computer equipment

    The employee is frequently required to stand; walk; use hands to grasp, feel or touch; reach with hands and arms; climb or balance; stoop; kneel; crouch; or crawl; and talk; or hear

    Moderate exposure to noise level in the work environment that is moderate to occasionally loud
    Occasionally lifts and/or moves up to 55 pounds

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