Geneva Metropolitan Area
Project Manager at SPINEART | Mechatronics Systems | Agile Project Management | Expertise in medical device prototyping, sterilization (autoclave), biocompatibility, usability, ergonomics, cybersecurity & lifecycle management Regulatory-compliant solutions adhering to medical standards, including ISO 13485, MDR 2027/745, and ISO 14971, designed for medical devices within Mechatronics Systems. EMC & RF Engineer at Advanced Oncotherapy | Metrology, high-precision & RF measurements | EMC certification, risk management | Development of test procedures & optimization of electromagnetic compatibility | Ensuring compliance with medical regulations R&D Testing Engineer at LEM | Metrology & precise measurements | Design & development of test benches | EMC Tests| Performance, aging, and reliability validation of high-precision sensors (industry, automotive, railway) Ensure the reliability of measurement systems in compliance with applicable standards. Evaluation of measurement-method performance: trueness, precision, and measurement uncertainty (ISO 5725). RF Engineer Fellow in the RF Group at CERN, I managed RF testing, including phase noise analysis, and developed electronic boards (PCB) for high-frequency applications. Tools: Proficient in LabVIEW, Python, Matlab. Standards: Quality management systems (ISO 9001, ISO 13485: Medical devices) - ISO 14971: Risk management. - ISO/IEC 17025: Competence of testing and calibration laboratories. - IEC 60601-1: Medical Electrical Equipment. - IEC 60601-1-2: Basic safety and essential performance for Medical electrical equipment and systems. In progress: Currently, I am pursuing the PRINCE 2 Project Management Professional certification.
Project management including: - ISO 13485, MDR 2027/745, ISO 14971 for Medical Devices - Management of DHF Files: Develop and maintain design history files, including design specifications. - Project Planning: Prepare and monitore project plans to ensure milestone achievement. - Design and FMEA: Develop technical designs and perform Failure Modes and Effects Analysis (FMEA) to minimize risks. - Competitor Analysis: Comparative studies and benchmarking of competitor products. - Risk Management: Create and implement risk management plans throughout the development cycle. - Usability (IEC 62366) and Ergonomics: Validate and optimize user interfaces and usability for improved customer experience. - Cybersecurity risk analysis for FDA purposes - Standards and Clinical Evaluation: Prepare lists of applicable standards and conducted clinical evaluations in compliance with regulations.
Electromagnetic Project Management : - EMC certification strategy in compliance with medical standards (IEC 60601-1-2) - Risk Management File strategy documentation (risk analysis, test procedures, test reports) - Calibration, instrument precision and metrology - Design measurement test benches - Carry out high-precision radiofrequency, high-current, and voltage measurements for power converters and radiofrequency power plants - Procurement strategy for complex EMC electronic test equipment - Hands-on experience with laboratory and field work using EMC test equipment such as EMI receivers, vector network analyzers, impedance analyzers and antennas Requirements for basic safety and essential performance with stakeholders : - Electromagnetic compatibility tests (application of IEC 60601-1-2 and collateral standards to all accelerator devices). - EMC pre-compliance emission/immunity tests (IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11 and CISPR11, EN55011) - Compliance with ISO 13485 Medical device standard - ISO 17025 : General requirements for the competence of testing and calibration laboratories
R&D projects on high precision transducers in the railways and industry applications: - Characterization and development of test benches. - Performance analysis. - Aging tests (temperature, humidity) to ensure product durability. - Conducting vibration tests (failures, product reliability). - Laboratory test measurements with safety requirements IEC 61010 for electrical equipment and their accessories - Laboratory immunity test and measurement techniques in Electromagnetic compatibility (EMC): IEC 61000-4-2, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6 - Data analysis, tests report and documentation - Thermal model measurement and modelization (MATLAB) dedicated to different type of tranducers, knowledge transfert to TCS for customers service. - MTBF and failure rate calculation (Item software): IEC 62380 Electronic Reliability Prediction Laboratory project management for test benches development and monitoring (NI LabVIEW): - essential performances characterization - write accurate test reports and maintain tests reliability - analyse deviation from the performances and statistics analysis - solve problems - planning and deadlines management
Radio Frequency Feedback Control development projects: - Development of universal electronic boards (12 layers PCB) based on FPGA both in analog and digital part (VHDL programming) in the low-level control group. Design, optimization and simulation dedicated to ultra-low phase noise providing local oscillators (LO) and multi-clock outputs via the backplane to others VME electronic modules. - Phase noise study and implementation done with a state-of-art PLL and custom oscillators (VCOs) to achieve clock jitter performance. - Clock jitter measurements @330 MHz (Jitter=120 fs RMS equivalent phase noise integrated bandwidth=[10Hz-10MHz]). - To produce and maintain accurate supporting documentation. - Collaboration with the beam instrumentation group Several applications to multiple RF frequencies from 100 to 800 MHz (different machines purpose: LINAC4, SPS200, SPS800, ISOLDE, SPL... a complex chain of accelerators).
Camera PET project on scanner prototype study and development : - Focus on testing and characterization of scintillating crystal radiation detectors composed of NaI & Lyso crystals, photomultipliers (PMT) & MCP (micro-channel plates). - Development of complete automation bench dedicated to crystals measurement with coincidence trigger (NIM logic) and data acquisition architecture (Labview software and hardware controller). - Collaboration with industrial and academic partners in the frame of crystal clear.