Biosensor Engineering Project Lead | Medical Devices

? Perth, WA

Lead the development of breakthrough medical technology—from early prototypes through testing, manufacturing scale-up and market readiness.

Lead Group is partnering with an innovative Australian medical technology company developing biosensor technology to improve monitoring and clinical decision-making during childbirth.

We’re looking for a hands-on engineer with robust mechanical and product development experience who enjoys solving complex technical problems and taking ownership of delivery.

The opportunity

Combining technical project leadership with practical engineering, you will work across product design, verification and validation, supplier development and manufacturing transfer.

Your responsibilities will include

- Leading mechanical and integrated product design, including precision components, materials, tolerances and DFM/DFA.
- Owning drawings, CAD models, specifications, bills of materials and controlled engineering changes.
- Planning and delivering verification and validation activities, bench testing and engineering investigations.
- Maintaining design-control documentation within an ISO 13485 quality system and supporting regulatory submission evidence.
- Working with suppliers to resolve component issues,



improve quality and support manufacturing scale-up.
- Collaborating with engineering, automation, quality, manufacturing and scientific teams to move development forward.

About you

You bring

- A degree in Mechanical, Biomedical, Mechatronics, Manufacturing Engineering or a related discipline.
- Medical device product development experience, with practical mechanical design capability.
- Strong understanding of ISO 13485 design controls, V&V; and familiarity with FDA requirements.
- Experience owning specifications, supplier technical documentation and engineering changes.
- The ability to lead technical projects while remaining actively involved in prototyping, testing and troubleshooting.

Experience with Class III/high-risk devices, biosensors, electrochemistry, sensor calibration or commercialisation would be highly regarded.

Why consider it?

This is an opportunity to take meaningful ownership in a growing, multidisciplinary start-up, work closely with technical specialists and help translate innovative technology into a reliable, manufacturable medical device.

If you enjoy technical challenges, practical experimentation and seeing your work progress towards clinical use, I’d welcome a confidential conversation.

📌 Biosensor Engineering Project Lead - Medical Devices (Perth)
🏢 Lead Group
📍 Perth