Management of engineering teamProduct roadmapTechnical leadingPatents

- Design of the hardware architecture (integration of an industrial robot in a mobile cart)- Design and develop electronics and firmware of our robotic end-effector (STM32, capture outputs of ~200 sensors, computation of 2D position & orientation of tool)- Manage robotic & software engineers- Technical lead on problems met by engineering team: + model parameters estimation and optimization, + 3D registration Key achievements: demonstation of prototype to one of the biggest orthopaedic world-company at AAOS 2023, 1 year after the creation of the company

● In charge of Design Control for system: - writing & verification of requirements of embedded software applications, traceability with design & tests - Leads risk management activities (Preliminary Risk Assessment, Design Risk Assessment (dFMEA)) - setup methodology for cybersecurity risks assessment of medical devices● Coordinate normative testing with outside test labs: AIMD testing (EN45502/ISO14708), 60601, compliance to RED (EN300328, EN301489)● Responsible of D&D activities for European project EIT-Health/RW4C

𝐍𝐨𝐭𝐞: 𝐉&𝐉 𝐚𝐜𝐪𝐮𝐢𝐫𝐞𝐝 𝐎𝐫𝐭𝐡𝐨𝐭𝐚𝐱𝐲 i𝐧 2018, 𝐅𝐞𝐛𝐫𝐮𝐚𝐫𝐲Role: DHF leader (on the Surgical Station and associated software parts) & Electrical tech leaderMain activities:- gathering and analysis of the product-level requirements- determination of the applicable regulatory requirements related to the IEC-60601 (v4) IEC-62366 (2015) standards and FDA guidances (e.g cybersecurity guidance)- proposals of technical solutions (software/hardware) to meet product and regulatory requirements- electrical design (to fullfil the requirements of the IEC 60601-1 v4 standard), - hardware design (to meet safety requirements: general HW architecture, design of electronic boards)- software architecture (safety applications running on RealTime operating system)- technical solutions to meet requirements related to the cybersecurity.Management: 2 engineers (direct reports) + up to 4 consultantsCollaboration with J&J teams all over the world (USA, Europe, etc...) on various topics (software development, supply chain for electrical parts, etc..)

In keeping with activities I had in the last 9 months I spent at MinMaxMedical, I was focused on the design of the system controlling a robot dedicated to maintain the position of a sawing blade, in the context of TKA surgery.This included notably: ● choice of HW design to comply with 60601 requirements● design of software architecture to meet realtime compensation and safety requirements (realtime software applications design using Linux with RT-PREEMPT patch)● setup methodology for cyber security risks assessments of medical devices and conduct PoC studies to solve maintenance issues

During this period, I was in charge of the design and prototyping of the so-called navigation station for surgical procedure.This experience requires skills in * electrical and electronical fields (design of system compliant with IEC-60601-1 standard)* embedded computing* realtime operating system

● In charge of Design Control activities (according to En62304) for software librairies designed to meet customer needs: - gathering of user needs/Design inputs - writing of specifications and test protocols - release of new versions● 4-persons team management

● 01/2007 - 12/2007: 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐋𝐞𝐚𝐝𝐞𝐫 𝐟𝐨𝐫 𝐚 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐭𝐚𝐫𝐠𝐞𝐭𝐢𝐧𝐠 "𝐊𝐢𝐝𝐧𝐞𝐲 𝐅𝐥𝐮𝐨𝐧𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐨𝐧" - 𝘈𝘤𝘵𝘪𝘷𝘪𝘵𝘪𝘦𝘴: Writing of technical file for CE marking (specifications, testing protocol, design documentation) for the "Kidney Fluonavigation" application ; Preliminary and design Risk assessments for product; Design and development of the application (GUI, algorithms, etc..); - Collaboration with clinical team for the device validation - 𝘈𝘤𝘩𝘪𝘦𝘷𝘦𝘮𝘦𝘯𝘵𝘴: CE marking of the system (Q1/2008)These activities were executed under control of the QARA team of the Praxim company http://membres-timc.imag.fr/Jocelyne.Troccaz/English-applis-cliniques_fichiers/english-fluoronav-du-rein.htm● 01/2008-02/2013 : 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐥𝐞 𝐨𝐟 𝐝𝐞𝐬𝐢𝐠𝐧 𝐚𝐧𝐝 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐨𝐟 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐚𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 𝐨𝐟 𝐭𝐡𝐞 𝐏𝐑𝐎𝐌𝐀𝐏(𝐂) 𝐒𝐮𝐢𝐭𝐞: - V1: Localization of prostate biopsies cores using 3D transrectal ultrasound without external 3D localizing device - V2: MRI/3D TRUS fusion for better targetting of suspicious area in the field - V3: Prostate biopsies under 3D transrectal ultrasound guidance in second look 𝘈𝘤𝘵𝘪𝘷𝘪𝘵𝘪𝘦𝘴: Design control: Writing of technical file for CE marking (specifications, testing protocol, design documentation); Preliminary & design risks assesments for "Software As MD"Collaboration with clinical team for system validationTech Leader of team of 3 development engineers (starting Q4/2011)Contributor to the QMS for ISO13485 certification of the company (Design and Development procedure complying with EN62304 requirements, production activities)𝘈𝘤𝘩𝘪𝘦𝘷𝘦𝘮𝘦𝘯𝘵𝘴: - CE marking of PROMAP V1 in 2009, - FDA clearance for V1 in 2010 - CE Marking/FDA clearance of new versions on-the-go

- Research in medical images processing, analysis and registration.- Clinical validation of projects for computer-assisted prostate brachytherapy and computer-assisted prostate biopsies.- Master and PhD students supervision

PhD Studentplease See "PhD" for more details