System V&V Engineer for Medical Robotics

Robeauté; Paris; Sur place; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health Insurance

Meal Vouchers

Transportation Reimbursement

Résumé du poste

Robeauté is redefining brain therapies with microrobotic platforms and seeks a System V&V Engineer to define and lead verification studies, ensuring ISO and FDA compliance. You will collaborate with R&D, QA, and Clinical teams to drive robust test programs and regulatory readiness during a pivotal growth phase.

You will develop V&V plans, supervise functional and safety tests, and ensure traceability within the Design History File, contributing to a high-assurance medical device product

Qualifications

• Must have in-depth knowledge of medical device regulatory standards.
• Experience documenting V&V plans, tests, and traceability.
• Strong understanding of system integration and verification processes.

Responsabilités

• Define system-level verification strategies aligned to requirements.
• Lead functional and safety testing with regulatory alignment.
• Integrate verification across hardware and software components.
• Analyze test results and drive CAPA actions.
• Support DHF content and design transfer activities.

Connaissances

ISO 13485

ISO 14971

ISO 10993

ISO 11607

FDA 21 CFR 820

Jama

Matrix Requirements

Statistical analysis

ISO 60601-1

ISO 62304

Formation

Bachelor's or Master's in Electrical Engineering

Outils

Jama

Matrix Requirements

Description du poste

Robeauté is redefining brain therapies with microrobotic platforms and seeks a System V&V Engineer to define and lead verification studies, ensuring ISO and FDA compliance. You will collaborate with R&D, QA, and Clinical teams to drive robust test programs and regulatory readiness during a pivotal growth phase.

You will develop V&V plans, supervise functional and safety tests, and ensure traceability within the Design History File, contributing to a high-assurance medical device product