Overview

Bring your mechanical engineering and design control background to our highly experienced and energetic 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.

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.

Qualifications

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

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

Learn more about us

Visit www.cookmedical.com.au/careers

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.

📌 Engineer 2, Post Market - 24-month fixed term contract (Eight Mile Plains)
🏢 Cook Group
📍 Eight Mile Plains