APS Level 6 Engineer / Scientist - Medical Devices
Contract Type
Contract
Reference
BH-373708
Science & Research
Negotiable
APS Level 6 - Engineer / Scientist x 2
Within theMedical Devices and Product Quality Division
Purpose of division :The division monitors medicines and medical devices approved for supply in Australia and works to ensure Australian and international therapeutic goods manufacturers meet specified standards.
Section responsibilities: The Biomaterials & Engineering Section 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 reported incidents, or as part of routine surveillance activities. Testing activities typically focus on performance and quality of medical devices involving biocompatibility, chemical, electrical, mechanical, materials, software, cyber security, and other relevant aspects.
Two contract positions to be filled:
1. First position is for period August 2025 to 31 January 2026
2. Second position is for period August 2025 to 10 March 2026
* Both positions are base in ACT.
* Monday to Friday 37.5 hours per week
* Primary work is Laboratory based and main duties to be performed in site at Office/Laboratory location.
* No security clearance required.
* Weekly paid
Education :
Qualifications relevant to electronics, and especially testing of batteries, battery-powered devices or appliances, or other low voltage electronics are highly desirable. Orbiomedical/electrical/mechanical/software engineering, materials science, cyber security and/or smart devices (including machine learning and artificial intelligence )
Desired Experience :
* Experience in testing of batteries, battery-powered devices or appliances, or other low voltage electronics is highly desirable.
* Experience working in a laboratory, in process automation and analysis processes, in designing and building test rigs and/or working to Standards is highly desirable.
* Experience working under a quality management system such as ISO 9001, 17025 or 13485 is desirable.
My client is a government agency within the Biomaterials & Engineering arena, and they are looking for Engineering, Scientists or candidates with equivalent work experience to undertake laboratory testing of medical devices and related work.
Two immediate contract opportunities exist within the section:
•Role one : With a specific focus on vapes and other battery-powered devices. This role has strong electronics focus and qualifications relevant to electronics, testing of batteries, battery-powered devices or appliances, or other low voltage electronics is highly desirable. This position is required to be filled for the period August 2025 to 31 January 2026.
•Role two to support other engineering work within the section. Applicants are sought with experiencerelated to biomedical/electrical/mechanical/software engineering, materials science, cyber security, and/or smart devices (including machine learning and artificial intelligence ). This position is required to be filled for the period August 2025 to 10 March 2026.
Key Responsibilities:
* Undertaking scientific and engineering-based technical investigations of medical devices to ensure they meet regulatory requirements, using a risk-based regulatory approach.
* Developing, delivering, and analysing scientific and engineering-based testing projects for medical devices, including preparing project proposals and testing plans.
* Preparing timely, high-quality reports that summarise key issues, making recommendations for regulatory decisions and providing rigorous technical analysisand advice on the results of the investigation/analysis/testing and on the implications of those results.
* Undertaking peer review of reports created by other team members as required.
* Providing expert advice to the Assistant Directors of the Section and other staff in the Division.
* Leading and contributing to innovation and continuous improvement activities in the Section and Branch.
* Developing and maintaining knowledge of state-of-the-art equipment and test methods and preparing proposals for the acquisition and use of new equipment.
Key Capabilities
* A good understanding of scientific and/or engineering principles and a capacity to undertake objective, critical analysis of scientific and engineering and regulatory issues, and to provide expert advice on this basis, in line with a risk-based approach to regulation.
* Effective communication skills including written and oral presentation and reports.
* An ability to provide technical input and support for issues outside own area of expertise.
* An innovative approach to problem-solving.
* An ability to work as part of a team to deliver results, even when priorities change.
* An ability to develop productive working relationships to identify opportunities and facilitate cooperation.
If you have the required educational and experience background, please submit your word formatted resume via the "Apply Button" and join a exciting and interesting laboratory / testing-based role.
Call Michael Knight on 0432 795167 to discuss your application or any questions you may have.
Closing day/date to get your application is Tuesday 29th July at 10am.
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