About: Our client is committed to producing cutting edge devices used by physicians world-wide. Our client is preparing to develop a manufacturing facility in Sydney. There is an exciting opportunity for an enthusiastic Design and Development Manager to head this challenge. The potential candidate will be responsible for: Development of Products Developing and monitoring the manufacturing process of these products Managing a team of enthusiastic engineers Solving any problems that arise within this manufacturing process The successful candidate will be self driven, hardworking Technical qualifications and experience: Bachelor of Medical Science, Biomechanical Engineering, Electrical and Electronic Engineering 5 years of experience in leading a team (essential) At least bachelor's degree in medical science, biomechanical engineering, electrical and electronic engineering, or a related field, Proven experience with designing and implementing new product, Hands on knowledge of manufacturing processes, Good understanding of ISO 14385 and IEC 60601 Must have full unrestricted Australian working rights, Skills: Strong analytical and problem-solving skills, Excellent written and oral communication, Capable of leading a team, High level of attention to detail, Can-do attitude and ability of taking on various tasks (including activities on production floor) About the role: Full-time, On-site Responsibilities: Responsibility for the management of all Design activities including Design Failure Mode Effect Analysis (DFMEA), Production Part Approval Process (PPAP) and Design Verification/Product Validation (DV & PV) testing, Liaise closely with all departments to fully understand design requirements, Provide support to production and investigate issues, Implement and support QA functions (quality records, product inspections) related to materials, supplies, and products, Support planned activities such as product building, inspections and testing Support manufacturing operation to implement a continuous uninterrupted flow of products Create standard operating procedures (SOPs) and work instructions (WIs) Renumeration: Salary packages are based on the skills and experience of successful applicants. If this opportunity resonates with you, we invite you to apply.