At a Glance
- Tasks: Lead post-market design activities for innovative medical devices and manage engineering projects.
- Company: Join a passionate team at a leading medical device company committed to improving lives.
- Benefits: Enjoy competitive salary, bonuses, training, and a supportive work culture.
- Other info: Great Place to Work® Certified with strong community engagement initiatives.
- Why this job: Make a real impact in healthcare while working on cutting-edge implantable devices.
- Qualifications: Tertiary qualifications in Mechanical or Biomedical Engineering and experience in regulated industries.
The predicted salary is between 82800 - 101200 $ per year.
Bring your mechanical engineering and design control background to our highly experienced and dynamic Post Market Engineering team. Are you results-focused with a passion for problem-solving and working on high risk implantable medical devices? This role will allow you to tap into your drive, initiative and technical abilities.
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.
Key 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 or support Corrective and Preventive Actions (CAPAs).
- Support engineering driven projects or programs including working with external contractors on post-market projects where applicable.
- Lead or Support evaluation of design related supplier changes.
- Interact effectively and professionally throughout various levels of the global organization.
In return for your hard work and commitment you will have access to the following:
- Stability of a long-established company
- Values recognition awards
- Competitive annual salary
- Annual Leave loading
- Quarterly bonus based on manufacturing metrics
- Subsidised cafeteria and excellent working conditions
- Ongoing support, training and development
- Strong inclusive culture that values its people
To succeed in this role, you must have the following:
- Tertiary Qualifications in Mechanical, Biomedical Engineering or equivalent essential
- Knowledge and experience in the application of design controls essential
- Previous experience working within a highly regulated industry, medical devices preferred
- Knowledge and experience in the application of risk management techniques essential
- 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 and communication skills essential
- Intermediate statistical data analysis skills and experience desirable
Candidates applying to this role must be a permanent resident or citizen of Australia.
We encourage applications from Indigenous Australians, people with disability, those from diverse cultural backgrounds, people from the LGBTQI+ community and anyone else who wants to be a part of our Cook Australia family.
Mechanical Design Engineer in Brisbane employer: Cook Medical Inc.
As a leading innovator in the medical device industry, we offer Engineering Interns a unique opportunity to gain hands-on experience in a supportive and inclusive environment at our Eight-Mile Plains facility. Our commitment to employee growth is reflected in our Great Place to Work certification, where you will receive ongoing mentoring and training from experienced professionals while contributing to meaningful projects that improve lives. With competitive pay, onsite amenities, and a culture that values diverse perspectives, we are dedicated to fostering a workplace where every intern can thrive and make a real impact.
