About: Sabre Medical is dedicated to designing and delivering reliable and innovative packaging solutions for our customers' medical devices, specialising in crafting custom-designed packaging solutions. Our site includes four cutting-edge Class 7 and 8 cleanrooms on-site. These are equipped with the highest quality machinery, equipment, and technologies (including a Thermo forming machine imported Germany) We employ over 30 people in our Quality, Design Engineering, Facilities and Production teams and are continuing to grow. We work with startups and help their R&D in bringing new and innovative medical device technologies to market. This requires an extensive range of testing and validation, using bespoke equipment and machines We take pride in our ISO 13485 accreditation and are conveniently located in Lane Cove West NSW 2066. We have recognised the need to appoint an R&D Facility Process Development Engineer. Responsibilities: The upkeep and preventative maintenance of facilities and site equipment - ensuring system compliance at all times Demonstrated expertise in Lean Manufacturing, Operational Excellence, Root Cause Analysis and Technical Troubleshooting Demonstrate expertise in plastic thermoforming - tool design for manufacture, setup and operation. They will need to undertake projects as directed from engineering and management and work with the engineering team to improve project and programme visibility. They will seek and realise opportunities for process improvement, automation, and production efficiency The ability to work on customer projects for packaging or device development and testing and complete customer validations and testing as necessary. As this is a management role - you will also need to foster a team culture of accountability, compliance and engagement in which employees remain comfortable discussing issues or concerns - training and mentoring staff as required Experience and Qualifications At least a Mechanical Engineering degree and further study in any Medical Technology will be an advantage At least Two (2) years of Post Graduate experience in a regulated industry of Medical Devices manufacturing Have experience working within regulations such as ISO 13485, (Medical Devices) and ISO17025 Must have English with strong written and oral communication skills Team oriented skills for problem resolution and implementation of projects. Attention to detail, meticulous accuracy with written and numerical work. Problem solving - logical person. Strong interpersonal skills for a management role About the role: Full-time On-site The salary range is $90,000 -100,000