We are seeking an experienced Systems Engineer to join our team of multidisciplinary product design professionals in our mission to create advanced technology products that positively impact our world. You will lead the development of innovative medical devices and deep-tech products, ensuring they meet our high standards of quality, safety and compliance.
You will work closely with clients and colleagues to define, develop and realise complete product solutions from concept through to production. Combining systems thinking with practical engineering expertise, you will shape product architectures, guide technical decision-making and help bring complex technologies to life.
You will own system architecture, requirements, integration and product realisation activities, harnessing your passion and talent for designing products which are technically robust, commercially viable and ready for market success. Combining big-picture thinking with engineering rigour, you’ll help solve complex challenges while shaping the future of innovative technology products.
If you’re passionate about systems thinking, product innovation and creating better together, we’d love to hear from you.
To apply for this role you must:
- Submit a brief (1-2 page) summary of your relevant project experience describing some systems you have worked on, and your contribution to those projects.
- Be an Australian citizen, permanent resident, or hold a valid working visa
- Possess strong product development experience in the medical devices industry.
- Possess a relevant qualification from a reputable education organisation, such as a Bachelor or Masters of Engineering
Key Responsibilities:
- Completing system-level feasibility studies bringing deep-tech innovation to new industries.
- Liaising with clients, clinical stakeholders, and suppliers to ensure alignment and technical feasibility.
- Translating user, clinical and business needs into clear design inputs and requirements.
- Managing product risk through state-of-the-art evaluation, analysis, and traceable controls.
- Incorporating usability, human factors, and safety considerations into practical designs.
- Defining system architectures and interface documentation for multidisciplinary products.
- Leading traceable system design from user needs through requirements, risks, design, verification, validation, and manufacture.
- Developing complex medical or other regulated products from concept to production.
- Supporting design activities across multidisciplinary domains including electronics, software, mechanical and industrial design.
- Planning and supporting the execution of traceable verification and validation activities, including prototype testing and compliance management.
- Producing documentation packages to support manufacturing, regulatory approvals, and certification.
- Consulting in cross-functional technical design reviews.
- Supporting estimation, planning, and delivery of engineering work across projects.
- Contributing to process improvements which set industry best practice and optimise company quality systems.
- Mentoring junior engineers and contributing to team capability development.
What We’re Looking For:
- A passionate, detail-oriented systems engineer who thrives on delivering complex systems that improve our world by solving real-world problems.
- Proven experience delivering medical devices from concept to manufacture.
- Strong communication skills and the ability to work effectively in a fast-paced, collaborative consultancy environment.
- A proactive mindset with a strong sense of ownership
and accountability for design outcomes.
Minimum Criteria:
- 8+ years of experience in systems engineering within multidisciplinary product development environments.
- 3+ years of experience in medical device development.
- Experience generating and maintaining design documentation packages for regulated industries.
- Experience designing and documenting for regulatory pathways (e.g. FDA, TGA, MDR)
- Experience generating and controlling documents and other work products within an ISO13485 Quality Management System
- Experience with product development from concept through to manufacture
- Experience with verification and validation processes, risk management, and regulatory and compliance frameworks for medical or regulated products.
- Experience generating solutions that are appropriate for both time and cost considerations appropriate to the problem at hand.
- Strong problem-solving and analytical skills
- Excellent verbal and written English communication skills
- Ability to work both independently and collaboratively within cross-functional teams
In addition, an ideal candidate will have at least some of
the following:
- Experience building documentation packages and
supporting device regulatory approval through the FDA’s 501(k) pathway.
- Strong understanding and technical literacy across electronics, embedded systems, software-controlled products, and mechanical integration.
