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    Manufacturing Engineer - Minnetonka, United States - Collabera

    Collabera
    Collabera Minnetonka, United States

    2 weeks ago

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    Description

    As a Process Development Engineer within EP division, you will play a pivotal role in developing and refining process technologies to meet product design and performance requirements. Your expertise will contribute to the enhancement of manufacturing techniques, materials selection, and process engineering planning, ultimately ensuring the seamless production of life-saving medical devices.

    Responsibilities:

    • Execute Process Validations, including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Product Performance Qualification (PPQ).
    • Author and release IQ reports, documenting the successful installation and functionality of equipment and processes.
    • Conduct troubleshooting of process equipment to identify and resolve issues promptly, ensuring minimal disruption to production.
    • Collaborate with cross-functional teams to develop processes aligned with product specifications, while considering process and test method capabilities.
    • Maintain awareness of relevant work environment regulations, such as OSHA requirements, to ensure compliance and promote a safe working environment.

    Required Qualifications:

    • Bachelors degree in engineering or a related field.
    • Minimum of 3 years of experience in process development or manufacturing process engineering.
    • Proven track record in developing and validating medical device manufacturing equipment, fixtures, and technologies, with a focus on design for manufacturability (DFM) preferred.
    • Familiarity with performing installation qualifications (IQ).

    Preferred Qualifications:

    • Background in introducer/catheter processing, providing additional insights into specialized manufacturing processes within the medical device industry.
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