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    Manufacturing Validation Engineer - Irvine, United States - Diverse Lynx

    Diverse Lynx
    Diverse Lynx Irvine, United States

    2 weeks ago

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    Description


    Job Title Manufacturing Validation Engineer "ROLE" as per TCS Role Master Product Engineering Lead Candidate for this position to be offered with TAIC or TCSL as Entity TCSL Relevant Experience (in Yrs) 4+ years of experience & demonstrated proficiency in manufacturing validation & providing ongoing technical support is preferred with evidence of continued self-development.

    Work experience in the Medical Device industry.

    Technical/Functional Skills Knowledge of Medical Equipment manufacturing processes GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs Ability to specify & qualify Assembly, Tooling, Gage equipment and Fixture equipment Knowledge in the areas of Process validation, Statistical process control, Product design & DFMA (Design for Manufacturing & Assembly), Plastic & metallic materials & processing and Applied Statistics Knowledge of biocompatibility in medical device industry Demonstrated ability to interpret the engineering drawings i.e.

    , GD&T (Geometric Dimensioning &Tolerancing)

    Understanding of Process development & design and Quality Function Deployment Excellent Analytic problem solving, Broad business planning, Cross-functional integration skills Demonstrated understanding of Ergonomics and financial analysis skills preferred Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred Understanding of Marketing & market research strategies Personal computer skills, Windows:

    word processing, project planning, presentation, e-mail, web browsers & spreadsheet software Training & experience in Good Manufacturing Practices & ISO 9000 is required.

    Experience Required 4+ Years 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:

    Train mechanics & operators on internal processes & equipment requirements Perform Installation Qualification, Operational Qualification, Process Qualification Develop validation protocols, qualify first articles, complete process capability studies & process validation on both internal & supplier processes using appropriate statistical techniques Prepare reports as per project requirement Actively participate in setting overall project objectives, direction & contributing in other functional areas as needed Work with R&D as needed to support process development, process improvements and process transfer activities Can travel to plant site at Mexico if required 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 such as safety & environmental Follow all company safety policies & other safety precautions within work area.

    Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination.

    All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role.

    We promote and support a diverse workforce across all levels in the company.
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