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    Manufacturing Engineer - Minneapolis, United States - a Medical Devices company located in MN

    a Medical Devices company located in MN
    a Medical Devices company located in MN Minneapolis, United States

    4 weeks ago

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    Description

    Manufacturing Engineer (Contract)

    Submit your CV and any additional required information after you have read this description by clicking on the application button.

    RESPONSIBILITIES

    • Developing, implementing, and continuously improving manufacturing processes to enhance yield, reduce costs, and improve productivity.
    • Representing Process Engineering in R&D and Project Team meetings, providing technical expertise in technology transfers, analytical method development, validation, and process scale-up.
    • Conducting or managing process validations (IQ/OQ, OQ, PQ).
    • Troubleshooting production line issues related to yield, quality, and throughput.
    • Leading scaling up processes from development to full-scale manufacturing.
    • Supporting evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
    • Creating/updating manufacturing instructions, routings, bills of materials, and SOPs.

    QUALIFICATIONS

    • Minimum 4-5+ years of experience of medical device manufacturing.
    • Experience with Design Transfer and Process Validations at external suppliers (CMO).
    • Write and execute associated validations.
    • Strong analytical and problem-solving skills (DOE, SPC, Six Sigma)
    • Knowledge on Class II/Class III medical device manufacturing and related quality system regulations.
    • Demonstrates ability to consistently meet proposed timelines, applying competent use of project planning and project management skills.
    • Excellent oral and written communication skills; ability to communicate with technical and non-technical audiences.
    • Ability to effectively provide direction and support to external partners/suppliers.
    • Experience with electromechanical assemblies is preferred
    • Design for Manufacturing experience is preferred.
    • Fixture development experience is preferred.
    • Experience in early stage of product development is preferred.

    EDUCATION

    • Bachelors in Biomedical, Manufacturing, Mechanical Engineering, or related life sciences discipline
    • Six Sigma Certification.

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