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    Validation Engineer - Irvine, United States - Ascendum Solutions

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    Upper Management / Consulting
    Description

    ON SITE 5 DAYS A WEEK IN IRVINE, CA

    Full job description

    Make a meaningful difference to patients around the world. at our client's facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

    How you will make an impact:

    Improving manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement.

    Developing basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.

    Analyzing and resolving basic Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).

    Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

    Establishing project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis).

    Identifying opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes.

    Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work.

    Mainly will inspect, measure, analyze, audit, calibrate and test the instrumentation, equipment, machines and procedures.

    What you'll need (Required):

    • Bachelor's Degree in Engineering or Scientific field Required

    What else we look for (Preferred):

    Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

    Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills

    Basic understanding of statistical techniques

    Previous experience working with lab/industrial equipment preferred (if applicable)

    Good understanding and knowledge of principles, theories, and concepts relevant to Engineering

    Good problem-solving, organizational, analytical and critical thinking skills

    Good understanding of processes and equipment used in assigned work

    Knowledge of and adherence to our client's Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

    Strict attention to detail

    Ability to interact professionally with all organizational levels

    Ability to manage competing priorities in a fast-paced environment

    Must be able to work in a team environment, including immediate supervisor and other team members in the section or group; and may interact with vendors

    Ability to build stable working relationships internally

    Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.


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