Senior System V&V Engineer for Medical Device Robotics

Robeauté; Paris; Sur place; EUR 80 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health Insurance

Meal Vouchers

Transportation Reimbursement

Résumé du poste

Robeauté is seeking a System V&V Engineer to define and lead verification studies across our medical device portfolio, ensuring regulatory compliance and engineering excellence. You will establish system-level verification strategies, oversee functional and safety testing, and ensure integration of hardware and software components.

You will collaborate with system, software and hardware teams, QA, Regulatory Affairs, and Clinical to ensure traceability, robust documentation, and timely design

Qualifications

• Bachelor’s or Master’s degree in Electrical, Biomedical, Systems Engineering or related field.
• 5+ years of experience in system integration, verification, and design control within the medical device industry.
• Proven ability to develop and maintain verification documentation (V&V plans, test protocols, reports, and traceability) and execute design verification strategies.

Responsabilités

• Define the system-level verification strategies with full traceability to user and design requirements per ISO 13485, 14971, 10993, 11607 and FDA guidelines.
• Lead functional and safety testing aligned with design inputs and regulatory standards (ISO 60601-1, 62304, IEC 80001-5-1, IEC 82304-1).
• Collaborate with cross-functional teams to analyze results, identify root causes, and define corrective actions.
• Support validation and design transfer activities, ensuring DHF traceability.
• Interface with QA, Regulatory Affairs, and Clinical teams to meet regulatory submission and audit requirements.
• Participate in design reviews, risk assessments, and usability evaluations; promote rigorous documentation.

Connaissances

System verification

Regulatory compliance

ISO 13485

ISO 14971

FDA 21 CFR 820

ALM tools

Test planning

Formation

Bachelor’s or Master’s in Electrical/Biomedical/Systems Engineering

Outils

Jama

Matrix Requirements

Description du poste

Robeauté is seeking a System V&V Engineer to define and lead verification studies across our medical device portfolio, ensuring regulatory compliance and engineering excellence. You will establish system-level verification strategies, oversee functional and safety testing, and ensure integration of hardware and software components.

You will collaborate with system, software and hardware teams, QA, Regulatory Affairs, and Clinical to ensure traceability, robust documentation, and timely design