Job Description
Overview n
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Bring your mechanical engineering and design control background to our highly experienced and dynamic Post Market Engineering team.
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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.
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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.
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Responsibilities n
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Lead and/or assist in post-market activities for current products including:
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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.
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Preparing documentation to support submissions and responses to regulatory authorities.
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Lead or support Corrective and Preventive Actions (CAPAs).
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Support engineering driven projects or programs including working with external contractors on post-market projects where applicable.
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Lead or Support evaluation of design related supplier changes.
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Interact effectively and professionally throughout various levels of the global organization.
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Qualifications n
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To succeed in this role, you must have the following:
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Tertiary Qualifications in Mechanical, Biomedical Engineering or equivalent essential
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Knowledge and experience in the application of design controls essential
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Previous experience working within a highly regulated industry, medical devices preferred
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Knowledge and experience in the application of risk management techniques essential
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Documentation in accordance with strict quality management systems is an essential part of this role so the applicant must have valuable technical writing skills and attention for detail.
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Experience working across multiple projects and disciplines with good time management and communication skills essential
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Intermediate statistical data analysis skills and experience desirable
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In return for your hard work and commitment you will have access to the following:
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Stability of a long-established company
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Values recognition awards
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Competitive annual salary
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Annual Leave loading
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Quarterly bonus based on manufacturing metrics
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Subsidised cafeteria and excellent working conditions
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Ongoing support, training and development
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Strong inclusive culture that values its people
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Learn more about us
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Visit
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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.
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📌 Engineer 2, Post Market - 24-Month Fixed Term Contract (Queensland)
🏢 Cook Group
📍 Queensland