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    Manufacturing Engineer - Minnetonka, United States - LanceSoft, Inc.

    LanceSoft, Inc.
    LanceSoft, Inc. Minnetonka, United States

    6 days ago

    Default job background
    Healthcare
    Description

    Title: Manufacturing Engineer

    Location:Minnetonka, MN 55345

    Duration: 06 Months

    Job Description:

    • supporting our EP division.
    • Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
    • 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.

    Responsibilities:

    • 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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