Possibility of extension
Section: Our client supports public safety by testing medical devices that are marketed in Australia against appropriate standards to ensure they comply with legislated requirements. Products may be tested in response to a device incident report and often relate to areas of material science, biocompatibility, biomedical/electrical/mechanical engineering and more recently, cyber security.
Duties of position
Specific duties include:
- Conduct, analyse and report on testing of goods to verify that they meet the required quality standards, to support investigations conducted in response to public health and safety concerns and for the purposes of accreditation, standardisation and international harmonisation
- Draft laboratory reports documenting the results of testing for approval by testing or project managers
- Assist in the development of planned testing projects through undertaking literature searches, selecting products for testing, and drafting product requests
- Participate in the development of new testing methods and the establishment of their reliability and validity
- Prepare and maintain laboratory records of testing in line with quality system and accreditation requirements and record data in the information management system, ensuring the highest standards of accuracy and clarity
- Contribute to the development of high quality, evidence-based testing manuals and SOPs
- Maintain current knowledge of new testing methods and tools and train and guide new staff to develop their familiarity with testing methods and equipment used in the laboratory
- Update the laboratory inventory to ensure the availability of required consumables and liaise with suppliers to ensure that stocks of equipment and consumables are maintained
- Undertake testing, calibration and maintenance of laboratory instruments and equipment, and identify and resolve technical faults and contribute to the identification of the laboratory’s future equipment needs
- Contribute to the development and implementation of continuous improvement activities within the section.
Candidates must be able to demonstrate:
- An understanding of engineering (ideally mechanical or mechatronics relates) and of associated analytical techniques and testing protocols
- A capacity to undertake data analysis of data and an understanding of statistical methods
- An understanding of and capacity to work within a laboratory quality management system
- A strong capacity to pay attention to detail and to produce accurate, high quality work
- Strong communication skills including the ability to produce high quality written reports
- The ability to build and sustain positive working relationships with team members.
- The successful candidate will have at least a diploma as a Mechanical Engineer or Mechatronics Technician
- Diploma of Engineering (Mechanical/Mechatronics) or equivalent qualifications
- Hands on experience in, and working knowledge of, mechanical/mechatronics testing activities, or other testing activities relevant to medical devices.
0403 200 666