• Design Control Engineer

    Posting Date 5 months ago(3/8/2018 9:58 PM)
    Requisition ID
    2018-4016
    Job Location(s)
    Bloomington IN United States
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Inc.
    Category
    Engineering
  • Overview

    The Design Control Engineer at Cook Inc. provides guidance to all engineers, and others working outside of engineering, that interface with Design Control activities (21CFR820.30 and ISO 13485 Section 7.3).  This position is responsible for creation and maintenance of all aspects of the design controls system, which are required for medical devices throughout the product life cycle.  

    Responsibilities

    • Train and advise engineering teams on the use of the Design Control Procedures
    • Interface with Risk Management and other QSR work streams to ensure a cohesive approach
    • Identify areas of opportunity for improvement within Design Controls and implement solutions
    • Represent design control function in all regulatory and internal audits
    • Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth

    Qualifications

    • Minimum 4-year degree in Engineering, preferably in Mechanical or Biomedical Engineering
    • Minimum 5 years engineering experience in the medical field, preferably with Cook Medical

     

    Physical Requirements:

    • Works under general office environment conditions
    • Utilizes close visual acuity for working with computers and equipment
    • Frequently required to stand, walk, and hear
    • Occasionally required to lift up to 20 pounds

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