Freelancer profile translated to English.
Back to original languageAbout Jeremy
I am a biomedical engineer specializing in systems engineering and QARA from Centrale Lyon. With over 2 years of experience at GE HealthCare and Vermon Inc. What I can bring you: my skills in QARA, Quality Control, and V&V of your medical devices and health SaaS.
French
Native or bilingual
English
Native or bilingual
Can work on-site
Paris (up to 50km)
Experience
- Echomote -dispositif ultrasonBiomedical Engineer QARAHEALTH AND WELLNESSNovember 2025 - March 2026 (4 months)Lyon, France-Quality:Maintenance of the ISO 13485 quality management system.Management of non-conformities, CAPA, and corrective actions.Participation in internal audits and notified body audits.Monitoring of quality indicators and continuous improvement.-Regulatory Affairs:Preparation and updating of MDR technical files.Risk analysis according to ISO 14971.Support for clinical evaluations and post-market surveillance (PMS).European and international regulatory monitoring.-Achievements:Obtained CE marking for a Class IIa software medical device.Reduced CAPA processing time by 30%.Participated in several audits without major non-conformities.
- Vermon Inc/CREATIS,Medical Imaging Engineering and AITECHFebruary 2025 - July 2025 (5 months)Lyon, France– System specifications, identification of user needs and requirements to develop design steps, i.e., prototyping, simulation, and integration tools, to have a clear and concise roadmap from the beginning.– Conducting tests and verifications of existing systems for compliance with performance standards, especially (as the system will be used in optimal safety conditions, there are electrical risks beyond simple performance and image quality).– Modeled and simulated for experimental data acquisition, to produce a summary report (quality and technical document) of all regulatory standard criteria to subsequently improve, modify design anomalies, and harmonize everything.
- T2S Group (GE Healthcare filiale),Biomedical EngineerTECHSeptember 2022 - August 2024 (1 year and 11 months)Morocco– Quality control of medical devices – Preventive maintenance (regularly performed) and corrective maintenance (for unforeseen problems during use).– Collaboration with field engineers to assess problems with clients' biomedical equipment, implement repairs, and new installations.– Management of documentation related to operating policies and procedures. I also coordinated two incident response interventions transmitted by doctors in their clinics with internal teams (field engineers) and external suppliers through customer feedback.
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Education
- Biomedical Engineering: MedTech and Regulatory Affairs Certifications – Six SigmaEcole Centrale Lyon2025Biomedical Engineering : MedTech etAffaire réglementaire Certifications – Six Sigma
- MS in Medical Imaging Systems and AIEPISEN2022MS inMedicalImaging Systems andAI