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Are you a driven Medical Device Engineer looking to shape the future of targeted drug delivery? Join PolyActiva, a pioneering biotechnology company located in Notting Hill. We're transforming site-specific drug delivery through our unique polymeric prodrug platform – and we need a technically excellent and regulation-savvy engineer to help bring our medical devices to life.
About the Role
Reporting to the Head of Product Development & Technical Affairs, 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
What You'll Bring
Tertiary qualification in science or engineering (biomedical engineering preferred)
5+ years' experience in medical device development within the biotech or pharmaceutical 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
Highly Regarded
Experience working with combination products (e.g. injectable devices)
Familiarity with the commercial registration process of medical devices
Who we are?
PolyActiva, is a Melbourne based company, working to transform the way eye diseases like glaucoma are treated. Driven by innovation and purpose, we're developing a groundbreaking drug delivery platform that aims to improve the lives of patients by offering more effective, consistent, and convenient treatment options. Our lead product, an implant designed to reduce the burden of daily eye drops, is currently in phase 2 trials. Every member of our team plays a meaningful role in advancing this mission and shaping the future of eye care.
Why PolyActiva?
We offer a dynamic and purpose-driven work environment, where innovation is at the heart of everything we do. You'll be supported by a knowledgeable, passionate team and have the chance to make a real impact on the future of drug delivery.
Ready to make a difference in medical device innovation?
Apply now with your CV and a short cover letter outlining your suitability for this unique opportunity.
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Your application will include the following questions:Which of the following statements best describes your right to work in Australia? What's your expected annual base salary? How much notice are you required to give your current employer? How many years' experience do you have as a Medical Device Engineer? What's your highest level of education?
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