Design Engineer - Implantable Medical Devices

Overview Full time, 24-month contract, work from home 1-3 days per weekValues focused culture encouraging accountability, autonomy and collaborationUtilise your engineering and technical experience to make a real differenceAre you passionate about improving patient health outcomes? Would you like to join an organisation with an established history where you can work on high-risk critical devices? This role will allow you to tap into your drive, initiative, critical thinking and problem-solving abilities.The Opportunity:Reporting to the Team Lead, Post Market Engineering on a 2-year contract, you will bring your engineering and design control experience to our dynamic and collaborative Post Market Engineering team. This diverse role will be responsible for risk analysis and design activities on our existing endovascular graft implants to meet changing medical device requirements around the globe and take these devices into new markets. Responsibilities Lead and/or assist in post-market design activities for current products includingMaintaining Design History Files (DHFs) to ensure continued compliance with current state-of-the-art,Development of information for submissions and responses on current products in existing markets.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. Qualifications We are seeking people who align with our company values and have a passion for providing quality solutions to our patients. To be successful in this role, you will be able to demonstrate the following skills and experience:Tertiary qualifications in Mechanical Engineering or equivalent essential. Knowledge and experience in the application of Medical Device Design Controls essential.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 for detail.Demonstrated leadership skills with the ability to take ownership.Intermediate statistical data analysis skills and experience essential.Employee Benefits:Work from home 1-3 days per weekBase salary plus performance-based quarterly bonus and annual leave loadingPrioritise your physical and mental wellbeing with access to onsite gym and our employee assistance programSubsidised cafeteria, wellness room, prayer room and onsite parkingOngoing support, mentoring and professional developmentInclusive team culture with opportunities to join our community engagement initiativesAbout us:Since 1963, Cook Medical have been inventing, manufacturing, and delivering a unique portfolio of medical devices to healthcare systems around the world. We work closely with physicians to develop technologies that improve patients' lives. Because we remain family owned, we have the freedom to focus on what we care about: patients, our employees, and our communities. At Cook Medical, whether we service patients, customers or colleagues, we all share a culture and a set of core values. The reflection of Cook's seven values in our daily business activities is an expectation of us all. By acting with integrity, being transparent and treating everyone with respect we can truly collaborate and be open to different ideas and perspectives.Supporting a Diverse Workforce:We are proud of our diverse workforce and value individual contribution. We appreciate that every employee can add value to our Organisation in their own unique way and want to ensure that our company culture stays balanced and strong. 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.Community Commitment: Our community program seeks to have a positive, transforming impact on our people, the environment and our local community. The program has four pillars:Community Engagement: We support our local community through philanthropy, education and partnerships. Our employees have been at the forefront of these initiatives, and we're proud of their contribution to making our community stronger.Environment and Sustainability: We are committed to being good stewards of the environment by aiming to ensure that our practices and processes are sustainable and responsible.Employee Engagement: We invest in our internal community through developing our employees, supporting their wellbeing and promoting an inclusive and diverse culture.Reconciliation: We're exploring a pathway towards making a meaningful commitment to Reconciliation by strengthening our understanding and appreciation of Aboriginal and Torres Strait Islander peoples' cultures, history and diversity.Learn more about us:Visit /careers