Manufacturing Engineer - New Product Introduction — Eight Mile Plains, Brisbane

Expired

Full-time, permanent role, onsite Values focused culture encouraging accountability, autonomy and collaboration Utilise your engineering and technical experience to make a real difference Do you have experience in product development, are you looking for that next step in the medical devices industry? Work with an experienced team where you can share ideas, collaborate and learn from others. The Opportunity: Reporting to the Manager, Manufacturing Engineering, you will be responsible for providing engineering support for the introduction of new medical devices into production. This role includes sustaining and improving production activities, processes, and equipment, ensuring efficient and compliant manufacturing operations within a regulated medical device environment. Provide engineering support for manufacturing processes, reduce downtime, and ensure optimal product lead time is achieved. Diagnose and repair process equipment and associated facilities to maintain reliable operations. Evaluate, manage, and support Non-Conformance Records (NCRs), Change Requests (CRs), Corrective and Preventative Actions (CAPAs), and Supplier Change Evaluations (SCEs) related to manufacturing processes, procedures, equipment, or products. Implement new equipment and processes to drive continuous improvement and efficiency in the manufacturing environment. Develop and implement methods to monitor and assess manufacturing processes for quality and compliance. Perform process validation activities, including authoring protocols and reports and organizing validation tests. Provide specialist engineering support, working with internal stakeholders to maximize productivity and ensure non-conformances in the process line are rapidly resolved. Collaborate with cross-functional teams, including R&D, Manufacturing, Operations, Regulatory Affairs, and other departments, to drive technical decisions and solutions. Assist production and quality departments in maintaining and improving quality and production objectives while meeting established standards and regulatory requirements. Work with external vendors and other Cook companies to facilitate the introduction of new products and technologies. Employee Benefits: State of the art facility Base salary plus performance-based quarterly bonus and annual leave loading Prioritise your physical and mental wellbeing with access to onsite gym, our employee assistance program and company paid top hospital private health cover Subsidised cafeteria, wellness room, prayer room and onsite parking Ongoing support, mentoring and professional development Inclusive team culture with opportunities to join our community engagement initiatives 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, 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 www.cookmedical.com.au/careers 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: Bachelor’s degree in engineering (Mechanical, Biomedical, Manufacturing, or related field) or equivalent scientific qualification essential. Experience in product development and/or manufacturing environments, preferably in the medical device or other regulated industry essential. Experience with 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 desirable. Previous experience working within a quality management system essential. Knowledge of medical device design control requirements desirable. Knowledge and application of relevant national and international standards desirable. Intermediate statistical data analysis skills and experience desirable. Proficient in the Microsoft Office Suite (Word, Excel, PowerPoint) essential.