Gilles Forconi
Software Quality Assurance Manager and Software Project Manager at Debiotech SA- Claim this Profile
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Bio
Experience
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Debiotech SA
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Switzerland
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Engineering Services
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1 - 100 Employee
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Software Quality Assurance Manager and Software Project Manager
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Nov 2018 - Present
- As member of the quality department, supervise the Planification, execution and documentation of the development, verification and validation tasks assigned to research and development projects in accordance with regulatory requirements (medical devices)- Advise project managers and R & D engineers in the design, safety and quality aspects of ongoing software product development (risk analysis, software classification) - Review documents and design - Changes control.- Ensure the compliance of SOP and developed product with standards like IEC62304/82304/60601, ISO 14971/80002, UL-2900/ISO27001, ISO13485/21CFR820&11- Define the product lifecycle quality SOP's.- Administrate the application/product lifecycle management system (documentation management, QMS, KPI)- Ensure the training of new employees on the eQMS / ALM=> FDA Clearance of the peritonal Dialysis device (2022) Show less
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Software Project Manager
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Sep 2016 - Present
R&D Responsible for medical device software and hardware architecture, focused on conception of a new type of home haemo-dialysis device. Team leading and interface with stakeholder. Specification phase complete, simulation and prototyping phase in progress. Development of the Graphical User Interface for connectiviy between main control unit and external eHealth system.=> Project awarded by Venture and PERL (2020)
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Bracco
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Software Engineer
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Dec 2004 - Sep 2016
- Project management, Specifications, risk analysis, FMEA, user manual, human factor studies, development and V&V supervising, 510k file submission (as combined products) - Principal engineer interfacing with marketing, manufacturing, quality and technical service teams - Software development (Embedded and PC application, SaMD, eHealth) - Architecture & conception of medical devices (Hardware & software) - Graphical User Interface and usability study - Device Interfacing with eHealth system, interfacing for remote control from Scanner => Conquest of whole European market and FDA Clearance Show less
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IPM Group
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Telecommunications
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1 - 100 Employee
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Senior Software Engineer
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2002 - 2004
Development of software embedded in communication and payment systems (data encryption, securized transmission) - Conception of electronic cards => Deployment of Payment system in whole Portugal => Deployment of first Wifi HotSpot with payment system in Singapore Airport Development of software embedded in communication and payment systems (data encryption, securized transmission) - Conception of electronic cards => Deployment of Payment system in whole Portugal => Deployment of first Wifi HotSpot with payment system in Singapore Airport
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Massachusetts Institute of Technology
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United States
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Higher Education
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700 & Above Employee
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Senior Research Scientist
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2000 - 2002
Member of the R&D management board of the international experiment AMS, a detector of cosmic particles installed on the International Space Station - Software lead for the embedded data acquisition system (FPGA based) - Participation to the Design of hardware (avionics, electronics, thermo) - In charge of validation of Embedded electronics for space environment, in collaboration with NASA and CSIIT (Taiwan). Member of the R&D management board of the international experiment AMS, a detector of cosmic particles installed on the International Space Station - Software lead for the embedded data acquisition system (FPGA based) - Participation to the Design of hardware (avionics, electronics, thermo) - In charge of validation of Embedded electronics for space environment, in collaboration with NASA and CSIIT (Taiwan).
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Helsinki Institute of Physics
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Finland
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Research Services
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1 - 100 Employee
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Project leader
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1998 - 2000
- In charge of the conception of a new type of detector (kind of camera using pixel detectors) dedicated to run in very hostile environment (ultra high vaccum, very intensive irradiations, very low temperature 160°K) dedicated to be installed on LHC at CERN - Promotion of the "Forward detectors" project - Search of solutions, integration of the project in a complexe infrastructure - Search of partners - Coordination of a small teams of engineers and physicists (20) implying a large variety of disciplines: cryogenic system, UHV, micro mechanics in ceramics, pixel detectors, magnetic optics, RF. Show less
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Massachusetts Institute of Technology
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United States
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Higher Education
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700 & Above Employee
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Research Scientist
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1993 - 1999
- Scientific Research in High Energy Physics, large scale data analysis - Promotion/simulation/feasability study of fast Particle Detection device using an hardwired Neural Network System - Management of a team of research using soft neural network to discriminate photons from other particles - Presentation of results & redaction of scientific publications - In charge of development and maintenance of a large trigger control system (running 24h/24h) - Development of a ultra fast simulation tool for particle detectors Show less
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University of Geneva
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Switzerland
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Research Services
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700 & Above Employee
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Professor Assistant
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Jan 1987 - 1993
- Design and realization of a high speed data acquisition and triggering system (Hardware and software) dedicated to the Time Expansion Chamber of the L3 Experiment at LEP (CERN) - Design and realization of a calibration system dedicated to the time expansion chamber. - Realization of high Speed algorithms for event reconstruction and identification Embedded in on-line Data treatment system - Realization of the Data Acquisition, Control system and user interface of the charged particle trigger system - Data statistical analysis - large scale data analysis - Teaching (Statistics, Experimental Physics) Show less
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Education
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Université de Genève
Doctorate in Physics (PhD), High Energy Physics and Instrumentations -
Université de Genève
Diplôme es Sciences, Physique -
Armée Française
Certificat de Secrétaire Comptable, Administration / gestion des soins de santé -
Université de Genève
License en Physique, Experimental Physics