Engineering Technologist Sabre Group Lane Cove West, Sydney NSW Production, Planning & Scheduling (Manufacturing, Transport & Logistics) Full time About Sabre Medical Pty Ltd Working with an innovative company across a range of medical device technologies. The company is expanding to bring to market a new medical device technologies and integrate this production within our cleanrooms in Sydney, Australia. As an accredited company to ISO 13485, there is a continual development investing into new technologies that will manufacture medical devices. This is a role where the right person will enjoy being able to work across a range of evolving technologies both locally and from Europe. Description of the role. The role is an Engineering Technologist. It is intended that the person would be working closely with engineering design teams and integrate new processes into the production team via handling process review procedures. Establishing production documentation and coordination of the production team assigned to the new process. This role has the authority to establish and complete change to bring about new technologies being introduced in the most efficient way possible with the appropriate level of Quality control. The incumbent is the Management Representative for production and as such is responsible for ensuring that the Quality Systems are integrated and blend with production in an effective way. The objective for this role is to ensure our production teams can produce safe and effective products, sterilised and released for on going trials and distribution. RESPONSIBILITIES AND DUTIES Perform the function of Engineering Technologist: Ensure that the Product Process requirements are effectively established and efficiently maintained; reporting on issues relating to the production Team and Process to management. Coordinate the cleanroom team and resolve Process or technical issues that arise in the transfer of products to the cleanroom team from design. Train operators and interns in the standards of ISO13485 and ISO14971 (risk assessments) Develop processes within the team that are compliant to standards for medical devices ISO13485. Engage and handle appropriate Corrective and Preventive Actions (CAPA) and internal audits. Review and approve production qualifications and validation protocol Preparing the technical reports for new processes being setup in production. Assist in developing manufacturing processes and customer projects assuring compliance of operations and products to meet specifications and requirement Participates in new product development/design control as needed. Other duties may be assigned, as required. QUALIFICATIONS B Chemical Engineering - Biomedical Engineering - Bachelor Science or related Science field. EXPERIENCE AND QUALIFICATIONS Three (3) years of Process and Post Graduate experience in a Medical Devices manufacturing environment. Proficient in regulations such as ISO 13485, (Medical Devices) Regulations and applicable standards such as ISO14971, ISO11135 or ISO11137. English with strong written and oral communication skills. Working knowledge of Continuous Improvement Tools and Process validation experience. Computer Literate use of statistical programs Must have considerable foresight and planning abilities in order to achieve required objectives. Capability for analytical and strategic processes. Team oriented skills for problem resolution and implementation of projects. Problem solving - logical person. Salary Guide $75-$85K Please apply in confidence via the link.