About Bruce
French
Native or bilingual
English
Fluent
Experience
- FreelanceMedical device Security advisorFebruary 2023 - Today (3 years and 4 months)Montpellier, France- Cyber security for medical devices Governance Cybersecurity risk assessments Cybersecurity complaint handling Conduct, design and plan cybersecurity features Regulatory assessment over regulatory requirements Cybersecurity FMEA Internal audit Normative aspects : ISO 13485 ISO 14971 UL2900-1 UL2900-2-1 NF EN 60601 IEC 81001-5-1 IEC/TR 60601-4-5
- Quantum Surgical SASSystem engineer / Security AdvisorFebruary 2022 - February 2023 (1 year)Montpellier, FranceSector : Medical devices- Systems engineering System engineering process (INCOSE Handbook, AFIS) Requirement Based Systems Engineering (RBSE with reqtify) Systems architectures (CESAMES Systems Architecting Method) Model Based Systems Engineering (MBSE) Integration, Verification & Validation (IVV) Product Line Engineering Change Management- Cyber security for medical devices Governance Cybersecurity risk assessments Cybersecurity complaint handling Conduct, design and plan cybersecurity features Regulatory assessment over regulatory requirements Cybersecurity FMEA Normative aspects : ISO 13485 ISO 14971 NF EN 60601 AAMI TIR 57 IEC 81001-5-1 IEC/TR 60601-4-5
- Zimmer Biomet Robotics (formerly Medtech SA)System project leader / Risk project leaderNovember 2019 - February 2022 (2 years and 3 months)Montpellier, FranceSector : Medical devices- Systems engineering System engineering process (INCOSE Handbook, AFIS) Requirement Based Systems Engineering (RBSE with reqtify) Systems architectures (CESAMES Systems Architecting Method) Model Based Systems Engineering (MBSE) Integration, Verification & Validation (IVV) Product Line Engineering Change Management- Risk Management Risk evaluation Risk assessment Failure Mode and Effect Analysis (FMEA or AMDEC) Defect management- Cyber security for medical devices Governance Cybersecurity risk assessments Cybersecurity complaint handling Conduct, design and plan cybersecurity features Regulatory assessment over regulatory requirements Cybersecurity FMEA Normative aspects : ISO 13485 ISO 14971 NF EN 60601 AAMI TIR 57
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Education
- Doctorat, Ingénierie mécatronique, robotique et automatisationIMT Atlantique2018Doctorat, Ingénierie mécatronique, robotique et automatisation
- Maîtrise en concentration personnalisé, Mechatronics, Robotics, and Automation EngineeringUniversité du Québec - Ecole de Technologie supérieure2013Maîtrise en concentration personnalisé, Mechatronics, Robotics, and Automation Engineering