Ume Hani

+ Handle measure management system (project management) and manage the Changes in QMS + Handle the Data management system + Write the Standard operating procedures + Validation of software used in QMS + Represented QMS in surveillance audits and internal inspections + Currently developing a complaint management system + Handling the Traceability of Technical documents before and after CE marking

+ Development of a medical software in compliance with DIN EN ISO 62304 and DIN EN ISO 13485. + Used LabVIEW code to build the Maintenance Guiding Tool for the FLIP (Fast Liver Investigation Package) device + Defined and documented the user requirements and technical specifications + Designed the test cases for verification and validation of Maintenance Guiding Tool + Used NI Requirements Gateway software as a project management tool and traceability tool

+ Maintenance and handling of SOP and technical documents. + Designing of test cases for software validation of NI Requirements Gateway Software. + Updating the documents according to DIN EN ISO 13485 : 2016. + Creating and managing documents in Intra-server Data Management System

+ Study of microstructure and material properties of Conventionally cast and 3D Printed Co-based alloy (MAR-M-509) "MAR-M-509 material has similar properties of the Co-based alloy used in Knee replacement." + Experience in Sample preparation( Cutting, grinding, Precision polishing with diamond paste ) of Co-based metal for analytics such as GD-OES, XRD, SEM/EBSD. + Analysis of microstruture and metal properties of the metal after heat treatment at various temperatures.

+ Generated LabVIEW code for the Vialux Projector to generate patterns of LED light which pass through a Biosensor. + Designed CAD model in Autodesk Inventor of sensor-chip setup which was 3D printed.

+ Attend Breakdown calls. + Maintain device data records + Hands-on experience on Calibration of ECG machine, Ventilators.

Note: 1.30 Courses: Bio-materials, Medical Imaging, Medical statistics, Bio/Chemical sensors, Cellular and molecular Biophysics, Dynamic systems and Computer modelling, etc

Final Bachelor Thesis : “Designing Forearm fracture table for closed nailing in Adults" under the supervision of Dr. Vishwanath Yaligod of Sapthagiri medical science and research center, Bangalore