Manufacturing Engineer — Eight Mile Plains, Brisbane

Expired

Permanent position with excellent benefits Be actively involved in manufacturing and assembly processes Investigate and resolve engineering and manufacturing problems Are you seeking variety in your role? Do you have an interest in medical devices? This is an incredible opportunity to join an experienced team and provide support to a critical area within our organisation. Reporting to the Team Lead – Sustaining Engineering, this role will provide technical and engineering support for all medical devices manufactured at Cook Australia. This will include sustaining production activities, product materials, processes and equipment used to produce medical devices. Provide engineering support to manufacturing to ensure product delivery times is achieved. Provide engineering expertise and diagnosis to determine the root cause of a non-conforming process, equipment, or facilities to help achieve reliable operation. Manage, evaluate, and support Non-Conformance Records (NCRs), Change Requests (CRs), Corrective and Preventative Actions (CAPAs) and Supplier Change Evaluations (SCEs) impacting approved medical devices and manufacturing processes. Perform equipment and process validations, including authoring of the protocols and reports. Perform all tasks in accordance with the Quality Management System to a competent standard. Work with cross-functional teams including R&D, Manufacturing, Operations, Quality Assurance and Regulatory Affairs to drive technical decisions and solutions. Provide specialist engineering support working with internal stakeholders to maximise productivity to ensure non-conformances in the process line are rapidly resolved. Assist production and quality departments to ensure quality and production objectives are maintained and improved meeting established standards and regulatory requirements. Work with external vendors and other Cook companies To succeed in this role, you must have the following: Professional engineering degree or equivalent experience, and a minimum of 3 years of prior relevant experience. Experience in product development and/or manufacturing environments, preferably in the medical device or other regulated industry - essential. A solid understanding of risk analysis/risk management techniques and concepts - essential. Experience performing Root Cause Analysis and developing Design of Experiments (DoE) - essential. Project management skills and experience will be highly regarded. Previous experience working within a Quality Management System (QMS) - essential. Knowledge of medical device design control requirements will be highly regarded. Knowledge and application of relevant national and international standards - essential. Intermediate statistical data analysis skills and experience - essential. Cook Can Offer: Stability of a long-established company Values recognition and service awards Base salary plus quarterly paid bonuses Annual Leave Loading Subsidised cafeteria & onsite parking Ongoing support, training and development Strong inclusive culture that values our people Candidates applying to this role must be a permanent resident or citizen of Australia. This role is to commence as soon as possible, and shortlisting will commence immediately. About 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, we use our high ethical standards and core values to guide our decisions and actions. We approach innovation by first listening to understand and then creating a solution. 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 www.cookmedical.com.au/careers