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    Manufacturing Engineer - Minnetonka, United States - Planet Pharma

    Planet Pharma
    Planet Pharma Minnetonka, United States

    1 week ago

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    Description

    The Opportunity:

    This position works out of our Minnetonka, MN location, supporting our EP division.

    As a Process Development Engineer (Manufacturing), 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

    • Evaluation of production equipment Production support and process validation Troubleshoot manufacturing process and equipment Protocol and report writing Generate and modify manufacturing process documentation Work with cross functional teams as required Develop and implement process improvements
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