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Minnetonka

    Process Engineer - Minnetonka, United States - Collabera

    Collabera
    Collabera Minnetonka, United States

    4 weeks ago

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    Description

    The Opportunity:

    • As a Process Development Engineer, you will perform analyses to develop process technologies based on product design and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations.

    What youll work on:

    • Execution of Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ)
    • Write and release IQ reports
    • Troubleshoot process equipment
    • Assist in developing processes based on product specifications and in consideration to process and test method capabilities.
    • Understand work environment issues (i.e. OSHA regulations, etc.).

    Required Qualifications:

    • B.S. in engineering
    • 3+ years' experience in process development or manufacturing process engineering
    • Experience developing and validating medical device manufacturing equipment, fixtures, and technologies with an emphasis on design for manufacturability (DFM) preferred.
    • Experience performing installation qualifications (IQ).

    Preferred Qualifications:

    • Background in introducer/catheter processing
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