• Medical Device Engineer

    Requisition ID
    2018-5640
    # of Openings
    2
    Job Location(s)
    Eight Mile Plains QL Australia
    Position Type
    Full Time
    Expiry Date
    27-12-2018
    Category
    Engineering
  • Overview

     

     

    Permanent Full Time Position to commence as soon as possible

    Eight Mile Plains location

    Attractive salary package & excellent working conditions

     

     

     

    Cook Medical is a global medical device manufacturer, committed to improving medical care worldwide.

     

    We are seeking the services of dedicated Post Market Engineer to join our team at our Australian head office located at Eight Mile Plains.

    About this role:

    Reporting to the Team Leader - Post Market Engineering, this role is responsible for leading and/or assisting in post-market design activities for current products, and corrective and preventive actions across the company, whilst managing engineering driven projects/programs.

    Responsibilities

    • Lead and/or assist in post-market activities for current products including:
      • Maintaining the design of the medical devices to ensure continued compliance with current state-of-the-art. This can include but is not limited to design changes, testing and risk management activities.
      • Preparing documentation to support submissions and responses to regulatory authorities
    • Lead Corrective and Preventive Actions (CAPAs)
    • Manage engineering driven projects or programs including working with external contractors on post-market projects where applicable
    • Support evaluation of design related supplier changes
    • Interact effectively and professionally throughout various levels of the global organization and with external contractors
    • Ensure personal compliance with COOK values, quality system procedures, policies and relevant medical device standards and regulations
    • Conduct education/training events and activities for the R&D team

    Qualifications

    • Tertiary Engineering Qualifications essential
    • Knowledge and experience in the application of Medical Device Design Controls desirable
    • Knowledge and experience in the application of Risk Management Techniques desirable
    • Knowledge and experience in the application of Corrective and Preventive Action processes desirable
    • Documentation in accordance with strict quality management systems is an essential part of this role so the applicant must have good technical writing skills and attention for detail
    • Experience working across multiple projects and disciplines with good time management skills desirable
    • Experience in a Medical manufacturing environment desirable
    • Demonstrated strong project management skills desirable
    • Intermediate statistical data analysis skills and experience desirable

     

    Please note only applicants that have full working rights within Australia are eligible to apply. Please apply with your CV and a cover letter outlining how you meet the requirements of the role. Shortlisting may commence immediately after advertisement posted.

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed