- Device design management and governance from pilot scale clinical volumes through to industrialisation, commercial scale-up and launch
- Integration across technical functions and systems with manufacturing organisations and equipment suppliers
- Technical input and collaboration with toolmakers, injection moulders, device manufacturers, automated assembly, packaging and test equipment suppliers
- Technical project management creating a clear development pathway to product launch
- Device and component design for manufacture (DFM) for commercial scale-up suitability
- Navigation through complex and demanding equipment qualification and validation processes Including technical support for complex multi cavity tooling and automated assembly
- Troubleshooting and device performance optimisation
- IFU and final packaging design and development