• Sustaining Engineer

    Posting Date 5 days ago(5/22/2018 3:01 PM)
    Requisition ID
    2018-3722
    Job Location(s)
    Winston-Salem NC United States
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Winston-Salem
    Category
    Engineering
  • Overview

    The primary purpose of the Research and Development Engineer (Sustaining) at Cook Winston-Salem is to design, test and technically document the feasibility, construction and production process of new and/or changed medical products.

    Responsibilities

    • Design and maintain Design History files

    • Design product modifications and/or develop process improvements as needed to meet standards, or for the purpose of product quality improvement

    • Design new product ideas as assigned by VP of Engineering
    • Build and test new product prototypes
    • Document the final product design
    • Assist in writing design and specification documentation for FDA application
    • Initiate and oversee the pre-production run of new products
    • Plan the ongoing production of the product
    • Consult with Production personnel for device changes/updates as necessary
    • Maintain a design file for each new product and turn that file over at product completion for permanent records
    • Call on vendors to assess raw materials
    • Call on physicians to discuss product ideas or evaluations
    • Attend various trade shows to source raw materials or to attend Company exhibitions

    Qualifications

    • Minimum 4 year degree in Engineering/Technology
    • Ability to work independently and remain self-motivated
    • Experience and understanding of the validation process

     

    Physical Requirements:

    • Ability to travel 25% of the time

    • Approximately 75% of the time is spent in a normal office environment requiring sitting and moving around the building, or in a "clean" environment Production setting requiring protective clothing and safety glasses

    • Approximately 25% of the time is spent in travel to various hospitals, physicians’ offices and public places

     

    Experience with Design Controls processes in the medical device/FDA regulated industry (i.e. build and maintain Design History Files - DFMEA) is preferred.

     

    Equal Opportunity Employer

     

    Qualified candidates must be legally authorized to be employed in the United States. COOK does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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