Senior Design Engineer

3 days ago


Eight Mile Plains, Queensland, Australia Cook Medical Full time

About the Role

This is an exciting opportunity to join Cook Medical's dynamic and collaborative Post Market Engineering team as a Senior Design Engineer - Medical Devices. As a key member of the team, you will be responsible for leading and/or assisting in post-market design activities for current products, including maintaining Design History Files (DHFs) to ensure continued compliance with current state-of-the-art.

Key Responsibilities

  • Lead and/or assist in post-market design activities for current products, including:
    • Maintaining Design History Files (DHFs) to ensure continued compliance with current state-of-the-art
    • Development of information for submissions and responses on current products in existing markets
  • Technical assessment of supplier changes to components and implementation of design changes to enable continued supply of product to market
  • Testing activities, including development of test protocols, liaison with external test facilities, analysis and reporting of test results
  • Review of product performance and safety, including root cause analysis and design solutions to resolve any identified problems
  • Manage engineering-driven projects or programs
  • Effective communication of technical analyses and risk assessments to cross-functional stakeholders

Requirements

  • Tertiary qualifications in Mechanical Engineering or equivalent essential
  • Knowledge and experience in the application of Design Control processes essential. Medical devices preferred
  • Knowledge and experience in the application of Risk Management Techniques essential
  • Previous experience working within a highly regulated industry. Medical devices preferred
  • Experience working across multiple projects and disciplines with demonstrated ability to meet deliverables essential
  • Demonstrated ability to interact effectively and professionally throughout various levels of a Global Organisation
  • Highly developed technical writing skills and attention for detail
  • Demonstrated leadership skills with the ability to take ownership
  • Intermediate statistical data analysis skills and experience essential

About Cook Medical

Cook Medical is a leading medical device manufacturer dedicated to improving patient health outcomes. Our dynamic and collaborative team is passionate about delivering innovative solutions that make a real difference in people's lives.


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