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    Medical Device Sr Manufacturing Engineer - Minneapolis, United States - MasterCompliance LLC

    MasterCompliance LLC
    MasterCompliance LLC Minneapolis, United States

    3 weeks ago

    Default job background
    Description
    Job Title - Sr Manufacturing Engineer (Medical Device)

    Job Location Nathan Ln N, Plymouth, Minnesota, United States of America, 55442


    Type:
    W2 contract

    This is a Fully Onsite role

    Job Description -

    Responsibilities may include the following and other duties may be assigned.

    Perform process development / process validation in support of the PMO road map.

    Create and complete validation documentation and route engineering change orders.

    Ability to remain self-motivated to push through required documentation to support changes.

    Quickly learn and collaborate on product design to help inform manufacturing changes.


    Make use of appropriate technical skills and tools, such as DOE, SPC, hypothesis testing, capability studies, Gemba walks, and "hands on" analysis, to perform in depth analysis, determine root cause, and identify corrective actions.

    Generate actionable ideas to reduce cost, cycle time and increase yield.

    Ability to understand how to flow requirements from a top-level design down to a manufacturing process specification.


    Must Have:
    Minimum Requirements

    Bachelor's degree in engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality

    Nice to Have

    Experience with leading/executing process validation activities (installations qualifications, process characterization, operational and performance qualifications)

    Experience interpreting mechanical drawings.

    Experience with DFMEA and PFMEA

    Experience with design of experiment (DOE) and other statistical methods.

    Work experience with the following:
    FDA Quality System Regulations, current Good Manufacturing Practices (cGMP), ISO 13485, ISO 9001 standards or equivalent.
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