Alexandra Goncalves

- Conduct experiments methodically, analyse data, interpret results and form conclusions. - Developing product specifications, drawings and quality plans. - Creating and managing the Product Development Validation Plan. - Verifying and running tests on sub-system level assemblies in development.

- Designing and developing microfluidic Lab-on-a-Chip devices for biological analysis of proteins, DNA and small molecules, and for single cell trapping. - Manufacturing of disposable microfluidic chips using different techniques: photolithography, etching, hot embossing, CNC machine.

- Developing and maintaining technical and non-technical documentation of medical products: product manuals, user manuals, helps of the software. - Responsible for the development, implementation and maintenance of the Quality Management System in accordance with International Standards including ISO 9001 and ISO 13485 requirements. - Managing all aspects of Regulatory Affairs including CE marking and FDA registration of the products. - Responsible for performing internal quality audits.

- Designed, modelled, prototyped and tested new centrifugal microfluidic devices for in-vitro medical diagnostic applications: Hematocrit measurement and Erythrocyte Sedimentation rate. - Designed of microfluidics devices using 3D design tools (Autodesk AutoCAD). - Prototyped Lab-on-a-disk platforms through different techniques (laser ablation, photolithography, cutting plotter, CNC machine). - Developed master thesis: "Development of a new method of clinical analysis in device Lab-on-a-disk".

Developed a state-of-the-art report regarding a prototype of a new medical device to prevent pressure ulcers in bedridden patients.