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    Validation Engineer - New York, United States - Ascendum KPS

    Ascendum KPS
    Ascendum KPS New York, United States

    1 week ago

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    Description
    Job description
    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.


    Education (Required):
    Bachelor's Degree in Engineering or Scientific field Required


    Preferred Skills:
    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 Edwards 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
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