
Alexandra Goncalves
Werdegang
Berufserfahrung von Alexandra Goncalves
- Bis heute 1 Jahr und 10 Monate, seit Okt. 2023
Regulatory Affairs Manager
Mika
- 2 Jahre, Jan. 2018 - Dez. 2019
Quality Manager
bess pro gmbh
- 4 Monate, Juni 2016 - Sep. 2016
Product Validation Engineer
DNA Electronics
- 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.
- 1 Jahr und 3 Monate, März 2015 - Mai 2016
Microfluidics Engineer
Genetics Microdevices Ltd
- 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.
- 4 Jahre und 7 Monate, Sep. 2010 - März 2015
Quality Assurance and Regulatory Affairs Manager
Kinematix
- 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.
- 1 Jahr, Aug. 2009 - Juli 2010
R&D Engineer
Biosurfit
- 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".
- 2 Monate, Juli 2008 - Aug. 2008
Researcher
Kinematix
Developed a state-of-the-art report regarding a prototype of a new medical device to prevent pressure ulcers in bedridden patients.
Ausbildung von Alexandra Goncalves
- 2008 - 2010
Biomedical Sciences
University of Beira Interior
- 2005 - 2008
Biomedical Sciences
University of Beira Interior
Sprachen
Portugiesisch
Muttersprache
Englisch
Fließend
Deutsch
Gut
Spanisch
Grundlagen
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