Le Grand-Saconnex, Geneva, Switzerland
MedTech leader with 16+ years of experience in Class III Active Implantable Medical Devices, spanning R&D, Verification & Validation, Manufacturing, and Operations. Over the past 7 years, I have led multidisciplinary neurotechnology programs from early development through regulatory approval and clinical deployment. My experience combines hands-on technical depth with cross-functional leadership, driving industrialization, process internalization, supplier strategy, and manufacturing scale-up in highly regulated environments. At Neurosoft Bioelectronics, I have focused on strengthening the interface between breakthrough bioelectronic innovation and robust operational execution — building scalable production systems capable of supporting high-density, next-generation neural interfaces. I am particularly interested in the convergence of advanced neurotechnology, data-intensive systems, and emerging AI paradigms. As bioelectronic platforms generate increasingly rich multimodal datasets, I see strong potential for deeper integration between implantable hardware, large-scale biological data modeling, and next-generation computational frameworks. I am motivated by environments where deep scientific innovation translates into reliable, scalable technologies with meaningful clinical impact. Expertise: - FDA pre-sub and IDE process experience until IDE approval - MDR 2017/745 (EU) and ISO 13485:2016 knowledge - Customer support for patients and clinicians in the EU - In-vivo long-term study - FELASA category C accredited Education - Expertise in SEM/FIB advanced imaging systems for nanostructure analysis - Cleanroom process control of Class III medical devices - ISO-10993 Biocompatibility testing - Risk Management per 14155 - Software Development Life Cycle ISO 62304
My role as Head of Product Development is to lead and support all design and development activities for the company's medical devices. This role is crucial in ensuring the successful delivery of innovative and high-quality products that meet both market needs and regulatory requirements. My duties are: ° Oversee and coordinate the entire product development process, from concept to commercialization with all relevant external stakeholder and internal team members. ° In charge of organizing, preparing and leading design reviews in collaboration with Quality and Regulatory Affairs Department ° Ensure products are designed in compliance with medical device regulations and standards. ° Responsible in defining needs of new subcontractors and preparing necessary documents that define collaboration: QA agreement, services agreement, consultancy agreement, or non-disclosure agreement, in collaboration with the CTO and QAM. ° Responsible to ensure appropriate implementation and the provision of Design & Development Procedure. ° Responsible to ensure that technical documentation activities are performed by internal or external resources with sufficient knowledge and experience and as per Good Practices established internally. ° Write and review documents related to design and development activities, such as test protocols and reports and verification protocols and reports, in collaboration with the C-Level and R&D Team.
° Responsible for Developing and implementing the company's technology roadmap ° Define company strategy and objectives with Board of Directors and C-Level ° Overseeing the development of new products and services ° Building and leading the technology team In summary, as the CTO, my mission is to foster a culture of trust, open-mindedness, and creativity within a high-performing team. I will drive the development of technological solutions that align with the company's overall mission and objectives while ensuring regulatory compliance
° Setting-up the strategy, roadmap, and vision for the directSTIM product line ° Secured CE-mark for Class III AIMD as a result of extraordinary teamwork of highly skilled, passionate and healthy team members ° Involved with submission of Design Dossier to notified body for CE-approval ° Passionate Leader of skilled cross-functional engineering, marketing, sales, and support teams ° Responsible for Design Control, Development and V&V activities ° Owner of directSTIM DBS System Development and Verification Planning ° Coordinating with Manufacturing and Operations for DVT needs ° Project Management with US partner ° Responsible for animal stereotactic surgeries and follow-up ° Writing of Verification and Validation Master Plans, reviewing of verification protocols ° Strong implication with Risk Management and Risk Analyses ° Responsible for acute and chronic studies on big animals (over 60 surgeries performed) ° Good knowledge of ISO-13485/10993/14708/60601/14155/62304/62366
° Responsible for Design and Development of a MDD class III Intra-Surgical Multiple Electrode Lead for Deep Brain Stimulation (DBS) surgeries in Movement Disorders. ° Construction of a clinical Dossier and interaction with ethics committee and Swiss agency for authorization and market supervision of all therapeutic and medical products. ° Project Manager of ALEVAs first medical device as legal manufacturer to be used for human trials in CH ° Lead of all DVT testing and elaboration of tools. Interaction with subcontracted labs for Biocomp and sterility testing ° Responsible for technical assistance during clinical studies in Surgical OR
Development of external BiVADs (Bi Ventricular Assists Devices) based on artificial muscles. Physiologic muscle movement is reproduced using SMAs (Shape Memory Alloys)
Development, optimization and quality control of artificial urinary devices.
Micro and Nano-systems engineer, Master degree achieved with the help of Prof. Renaud and his lab LMIS4.