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    Process Engineer - Irvine, United States - Diverse Lynx

    Diverse Lynx
    Diverse Lynx Irvine, United States

    2 weeks ago

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    Description

    Role:

    Process Engineer Locations:
    Irvine, CA -

    Onsite Types: 12+ months Contract Relevant Experience (in Yrs) 3+ years of medical device industry experience in design control and/or project engineering Job Description Must Have Technical/Functional Skills Knowledge about GxP Strong creative, analytical and problem-solving skills.

    Proficient at interpreting data and putting that data into a report. Experience in writing software specification documents. Process experience, ability to observe and understand manufacturing processes. Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred.


    Personal computer skills, Windows:

    word processing, presentation, e-mail, web browsers & spreadsheet software Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.) Good experience in Validation (IQ, OQ & PQ).

    Ability to read engineering drawings, GD&T, terminology, schematics. In-depth knowledge of design of medical devices preferred.

    Experience Required 3+ years of experience & demonstrated proficiency in Process engineering & providing ongoing technical support is preferred with evidence of continued self-development.

    Roles & Responsibilities Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and Corporate Pharmaceutical, procedures and guidelines, the duties and responsibilities for this position are:

    Programming, Setup, Update MOP Exceptional in validations, Executing DOEs and characterizations that build to robust validation Work in a cross-functional team environment.

    Creation of ECOs to upload documentation changes to PLM system. Travel to Juarez as per the requirement Know & follow policies & procedures related to work activities performed.

    in area of responsibility Complete training in area of responsibility within allowed time-period and periodic retraining in areas Federal, State, local and Company regulations, policies, and procedures.

    Generic Managerial Skills Meet delivery promise in terms of budget and timescales. Work within a multi-discipline team Education Bachelor's degree in engineering or science (Biomedical, Mechanical, Electrical, Biology, etc)
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