Join our Team
At TS NANO, we are focused on providing unique early diagnosis technology for medical and research users that improve outcomes and quality of life for patients suffering from diseases with multiple causes such as meningitis.
See our open positions below:
Reporting to
Chief of Product Development officer
Direct Reports
None
Term
part-time
The Role
Reporting to the chief of Product Development officer, you will play a critical role in managing the design, development, testing, and regulatory registration of our medical devices – from early-stage prototypes through to commercial launch.
This is a hands-on role requiring close collaboration with contract manufacturers, regulatory experts, and multidisciplinary teams to deliver high-quality devices that meet global standards.
Key Responsibilities
- Lead development of devices and packaging from clinical to commercial stages
- Coordinate external manufacturers and service providers to ensure on-time, on-budget delivery
- Design and implement human factors testing for clinical trials
- Develop and maintain regulatory documentation (Design History File, Risk Management Plans, etc.)
- Prepare registration documents for regulatory authorities
- Provide technical input into strategic planning, risk management, and troubleshooting
- Ensure compliance with ISO13485, FDA regulations, and internal quality systems
Key Selection Criteria
- Tertiary qualification in science or engineering (biomedical engineering preferred)
- 5+ years’ experience in medical device development within the biotech or MedTech sector
- Proven track record managing device design, validation, and regulatory compliance
- Strong understanding of medical device manufacturing and regulatory frameworks (Australia and US)
- Hands-on experience with FMEA, CAPA, root cause analysis, and risk management
- Excellent technical writing and project coordination skills
- Inventive and solutions-driven mindset
Desirable
Experience working with combination products (e.g. PoC devices)
Familiarity with the commercial registration process of medical devices
Location
Melbourne, Carlton
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Reporting to
R&D Team Leader
Direct Reports
None
Term
Pull-time
The Role
TS NANO is seeking a Graduate or Junior Analytical Biologist to join our dynamic team. This is an exciting opportunity for a recent science graduate with strong foundational lab skills and a passion for biology and life science innovation.
In this hands-on role, you’ll support a range of analytical testing activities, from preparing samples to developing and validating analytical methods, under the guidance of experienced biologist or medical researchers. You will contribute to the analysis of materials, data interpretation, method development, and reporting across a range of medical technology development projects.
Key Responsibilities
- Perform routine testing of materials (e.g. drug substances, cell culture, intermediates, finished products)
- Assist in developing and validating analytical methods
- Conduct data analysis and prepare technical reports
- Maintain and calibrate analytical equipment
- Review and prepare SOPs and other quality documentation
- Support regulatory submissions and perform literature reviews
- Collaborate effectively across the R&D and analytical teams
Key Selection Criteria
- Tertiary qualification in Science or medical (recent graduate encouraged to apply)
- Experience with biosensors with electro chemical reaction
- Understanding of analytical method validation
- Strong attention to detail and high-quality reporting skills
- Proficiency in Microsoft Word and Excel
- Good communication and teamwork skills
- Commitment to working safely and in line with OSHE guidelines
Desirable
- Experience with PC 2 lab design and environments
- Experience with virus and bacteria testing
Location
Melbourne, Carlton