Senior System V&V Engineer - Medical Robotics

Robeaute; Paris; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health Insurance

Meal Vouchers

Transportation Reimbursement

Résumé du poste

Robeauté is developing a microrobotic platform for brain therapies and seeks a System V&V Engineer to define and lead verification across medical devices. You will ensure regulatory compliance and engineering excellence within ISO 13485, ISO 14971, and FDA guidelines.

You will collaborate with cross-functional teams, drive test strategies, and mentor engineers while advancing a world-facing, high-precision medical technology.

Qualifications

• Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, 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.
• Hands-on experience with ISO standards and FDA guidance is preferred.

Responsabilités

• Define the system-level verification strategies with full traceability to user and design requirements per QMS and design control procedures.
• Lead functional and safety testing according to the verification strategy, ensuring coverage and regulatory alignment.
• Ensure verification studies on hardware and software components are integrated in the system verification strategy.
• Collaborate with cross-functional teams to analyze test results, identify root causes, and define corrective actions.
• Support validation and design transfer activities, ensuring integrity of verification evidence in the DHF.
• Contribute to continuous improvement of verification processes and test methodologies.

Connaissances

ISO 13485

ISO 14971

ISO 10993

ISO 11607

FDA 21 CFR 820

Jama

MatrixRequirements

V&V plans

Traceability

System integration

Formation

Electrical Eng

Biomedical Eng

Systems Eng

Outils

Jama

MatrixRequirements

Description du poste

Robeauté is developing a microrobotic platform for brain therapies and seeks a System V&V Engineer to define and lead verification across medical devices. You will ensure regulatory compliance and engineering excellence within ISO 13485, ISO 14971, and FDA guidelines.

You will collaborate with cross-functional teams, drive test strategies, and mentor engineers while advancing a world-facing, high-precision medical technology.