• Validation Engineer

    Posting Date 1 month ago(7/3/2018 2:11 PM)
    Requisition ID
    Job Location(s)
    Bloomington IN United States
    Shift Type
    Position Type
    Full Time
    Cook Inc.
  • Overview

    The Validation Engineer performs and documents validations of medical device manufacturing processes.


    • Validate and implement medical device manufacturing processes as
    • Identify equipment/fixture installation qualification requirements
    • Characterization of processes and their outputs/acceptance criteria
    • Written preparation of applicable validation reports that meet
    regulatory/company standards
    • Verification testing
    • Project management
    • Maintain accurate and timely reports and records

    • Must work and interact effectively and professionally with and for others
    throughout various levels of the global organization
    • Must strictly adhere to safety requirements
    • Maintain regular and punctual attendance
    • Must maintain company quality and quantity standards
    • Must have effective oral, written and presentation communication skills
    • Ability to work in collaborative and independent work situations and
    environments with minimal supervision
    • Ability to remain calm and receptive in fast paced situations
    • Must have excellent analytical and problem solving skills


    Physical Requirements/Work Environment

    • Works under general office environmental conditions.
    • Sitting for extended periods, utilizes close visual acuity for working with
    computers, equipment, etc.


    • Bachelors Degree in Mechanical Engineering, Mechanical Engineering
    Technology or Biomedical Engineering, or related field; or experience of
    such kind and amount as to provide a comparable background
    • Minimum 3 years experience in medical device process development or
    process validation



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