• Product Remediation Engineer

    Posting Date 3 months ago(2/12/2018 2:44 PM)
    Requisition ID
    2018-3891
    Job Location(s)
    Bloomington IN United States
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Medical Holdings
    Category
    Engineering
  • Overview

    The Sustaining Engineer at Cook Inc. will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.

    Responsibilities

    • Interface with Contract Engineers, Development Engineering, Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors and physicians as necessary to progress projects/tasks
    • Manage multiple project timelines, resources and responsibilities to achieve team, departmental, and company goals
    • Analyze risk using CEA and current FMEAs 
    • Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable
    • Identify user needs and develop into design input requirements
    • Formulate Verification & Validation Test Plan and collaborating with other COOK departments to execute testing

    • Update device and production specifications accordingly
    • May supervise / coach technicians or other engineering employees

    Qualifications

    • Bachelors Degree in Engineering or Engineering Technology, or experience of such kind and amount as to provide a comparable background
    • Previous project management experience preferred

    • Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving

    • Knowledgeable with Windows based software (i.e. Word, Excel, Project, Power Point, Visio)

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