Post Market Engineer

We are passionate about making unique, quality medical devices and connecting with people to improve lives. Founded on inventing, manufacturing and delivering medical devices, we provide healthcare professionals with the tools they need to help their patients return to living. Our commitment to innovation involves bringing new products to market and keeping existing products relevant to a changing healthcare landscape. We believe in using our business to help people and communities thrive by creating inclusive, supportive and healthy environments. We are proud of our history of innovative firsts and the impact we have on patients and communities. With manufacturing facilities in Australia, Europe and North America and offices in various locations around the world, we challenge ourselves to maintain a global perspective while focusing on local impact. Great Place to Work ® Certified™ Our seven core values shape how we work with patients, customers and each other. They guide the way we collaborate, support one another and remain deeply connected to the impact of our work. That’s why we’re proud to be recognised as a Great Place to Work ® , based on feedback from our employees about our culture, leadership and the pride we share in making a difference to patients every day. We’re committed to creating an environment where people feel supported, connected and valued. Community commitment Our community engagement program reflects our commitment to creating meaningful impact beyond the workplace through community partnerships, employee volunteering and philanthropy. We focus on key areas such as community support, education, environment, health and wellbeing, and vulnerable populations. The program encourages employee involvement and helps strengthen connections with the communities in which we live and work. Overview 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. 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.