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Senior Design Engineer

2 months ago

Eight Mile Plains, Queensland, Australia Cook Medical Full time

About the Role

We are seeking a highly skilled Senior Design Engineer to join our dynamic Post-Market Engineering team at Cook Medical. As a key member of our team, you will be responsible for leading and/or assisting in post-market design activities for our current products, including maintaining Design History Files (DHFs) and developing information for submissions and responses on current products in existing markets.

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.
  • 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 to 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 company dedicated to improving patient health outcomes. We are committed to innovation, quality, and customer satisfaction. If you are passionate about improving patient health outcomes and have a strong background in design control and risk management, we encourage you to apply for this exciting opportunity.