Sean Grech

• Compiled Verification Documentation, such as characterisation studies, protocols, reports, and TMV’s, forming part of a product's DHF documentation, for FDA / MDR compliance of a Class II medical device. • Created custom test setups for the testing of a multi-faceted, modular Heart-and-Lung Machine. • Communicated, liaised, and worked with a diverse team made up of over 100 engineers from different backgrounds including software, manufacturing, QA, and R&D.

• Formed part of the GE Global Healthcare service team required to manage and support the diagnostic imaging and treatment systems in Malta’s main public general hospital, Mater Dei. • Underwent training for the servicing and calibration of imaging devices including MRI, CT, X-ray, Mammography, and gamma imaging machines. • Continuously monitored, serviced, and performed the calibration/testing of GE Medical & Hospital Equipment in-line with international DICOM standards for Medical Imaging.

• Design electronics and prototypes of Class IIa and IIb medical devices • Developed algorithms for offline and online signal processing applications in C and MATLAB • Performed verification and validation exercises, including protocol development and application • Compiled DHF and quality documentation as part of a risk-based company model • Compiled CE 60601 and FDA 501k / De Novo dossiers • Managed project and created and implemented DDP's

Neurotechnology, Medical Imaging, Machine Learning, Computational Neuroscience.

Advanced Electronics, Systems and Control Engineering, PCB Design, Microcontroller programming, FPGA Programming.