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    Manufacturing Engineer - Irvine, United States - Intellectt Inc

    Intellectt Inc
    Intellectt Inc Irvine, United States

    2 weeks ago

    Intellectt Inc background
    Description

    Role: Manufacturing Engineer

    Location: Irvine, California, United States

    Duration: 6 Months on W2 (Contract only)

    Skills Looking For:

    • Setting up a new line which will end up being a commercial line and the plan is to get this line started in mid June.
    • Experience in installing equipment and equipment troubleshooting, running installation qualifications is a musthave. This will be the main focus of the role.
    • Must have experience working in a Cleanroom environment
    • Medical device experience is required.
    • Experience in other validation works will be a plus. Like execution of Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV).
    • Experience in Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Product Performance Qualification (PPQ).
    • Must have experience in writing and releasing IQ reports.
    • Help other fulltime engineers in developing processes.
    • Background in introducer/catheter processing is preferred.

    Education and Experience:

    • Bachelor's degree (BioMedical, Chemical, Mechanical engineering) with 3+ Years of experience is preferred.
    • Candidates with 8 years of experience are also fine if they are willing to work at a given rate and have the desired experience.
    • Masters degree is also fine if they have 2 years of medical device equipment installation and troubleshooting experience.

    Top 3 Skills:

    • Installation Qualification experience
    • Med device experience.
    • Equipment troubleshooting in installation.
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