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    Sr. Manufacturing Engineer - Brooklyn Park, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Brooklyn Park, United States

    1 month ago

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    Description
    Responsibilities :
    • Provides daily support of products, processes, materials, and equipment to achieve production goals.
    • Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
    • Troubleshoot, repair, qualify or validate new and existing equipment used to manufacture endovascular catheters.
    • Prepare testing and justification to support process, equipment and material changes.
    • Determine appropriate level of testing required per internal procedures, customer alignment and regulatory acceptance requirements provided.
    • Work with purchasing to optimize supply chains, recommend projects which reduce risk and/or reduce cost, and develop long-term commodity strategies.
    • Design, implement and monitor Statistical Process Monitoring system
    • Monitors daily yields and acts immediately to investigate and resolve issues to meet scrap and output goals.
    • Designs, procures, and fabricates equipment tooling and fixtures.
    • Performs troubleshooting on existing products/process problems as related to design, material, or processes.
    • Prepares validation protocols and reports to communicate results and conclusions.
    • May lead cross-functional project teams.
    • Identifies, implements, and manages equipment, labor and cycle time requirements to support production goals.
    • Trains and/or provides work direction to operators/technicians.
    • May perform or support TMV's.
    • Identify/Investigate Manufacturing issues (non-conformances) with root cause analysis and disposition production material through NCMR Process.
    • Responsible for notifying QA/QC of any observed or reported product quality issues so that appropriate action may be taken.
    Requirements:
    • 4+ years of relevant experience overall and 2+ years of experience within medical device manufacturing.
    • Familiar with catheter product design, manufacturing processes and applications.
    • Summarizes, analyzes, and draws conclusions from test results.
    • bility to work successfully in cross-functional teams.

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