System V&V Engineer

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 redefining the future of brain therapies through the first microrobotic platform designed to navigate the human brain with unprecedented precision. This new generation of medical microrobots will be able to diagnose, treat, and monitor the brain from within, overcoming the persistent limitations in treating neurological diseases that affect more than one in three people worldwide.

Since its founding in 2017, Robeauté has filed more than 50 patent applications. We recently raised €27 million in a Series A round led by Plural, Cherry Ventures, Kindred Ventures, and Brainlab, fueling our next phase of growth.

Now, as we scale, we are looking for a System V&V Engineer to define and lead robust system design verification studies across our medical device portfolio, ensuring regulatory compliance and engineering excellence.

What you’ll do

System Product/Device Verification

• Define the system-level verification strategies, ensuring full traceability to user and design requirements in compliance with our Quality Management System and design control procedures based on ISO 13485, ISO 14971 and FDA rules and guidelines.

• Develop and lead functional and safety testing according to the system verification strategy, ensuring coverage and alignment with design inputs and regulatory standards (e.g., compliance with ISO 10993 series, ISO 11607, System functional integration and robustness tests)

• Ensure that verification studies on the hardware and software components (e.g., based on ISO 60601-1 for electrical safety, 62304 for medical device software, IEC 80001-5-1 and IEC 82304-1 for cybersecurity) owned by R&D team are integrated in the system verification strategy.

• Collaborate with cross-functional teams to analyze test results, identify root causes of system issues, define corrective and preventive actions.

• Support validation and design transfer activities, ensuring the integrity of verification evidence in the Design History File (DHF).

Cross-Functional Collaboration

• Collaborate closely with system, software and hardware engineering teams to ensure seamless integration of all subsystems into a unified, high-performance product.

• Interface with Quality Assurance, Regulatory Affairs, and Clinical teams to ensure verification deliverables meet regulatory submission and audit requirements.

• Participate in design reviews, risk assessments, and usability evaluations, providing system-level insight into potential design or integration issues.

• Contribute to continuous improvement of verification processes, test automation strategies, and system-level test methodologies.

Training & Process Leadership

• Act as a leader within the System team, guiding integration of best practices and alignment across projects regarding system verification testing.

• Provide training and mentorship to engineers, project leads, and technical managers on regulatory expectations about design verification testing.

• Support cross-functional alignment on technical decisions, risk mitigation strategies, and verification priorities.

• Continuously monitor industry trends and evolving standards to adapt and improve internal design control processes, with specific attention to testing procedures.

• Promote a culture of rigor, traceability, and regulatory discipline across the product lifecycle.

Requirements

Technical Skills

• Working knowledge of ISO 13485, ISO 14971, ISO 10993, ISO 11607 and FDA 21 CFR 820.

• Hands-on experience with ALM tools (e.g., Jama, Matrix Requirements), statistical analysis.

• Familiarity with ISO 60601-1 and collaterals standards, ISO 62304, and cybersecurity standards (e.g., FDA premarket guidance) is a plus.

Personal Attributes

• Analytical, methodical, and rigorous, with a strong process orientation.

• Excellent communicator and trainer, able to influence cross-functional teams.

• Pragmatic and proactive, with a commitment to documentation and compliance.

• Comfortable working in a multidisciplinary and fast-paced environment.

Education and Experience

• 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.

A Mission That Matters: Join a team developing life-changing technology. Our microrobots have the potential to help over 1 million patients with neurological conditions.

World-First Innovation: Work on pioneering microrobots that navigate the brain for diagnosis and treatment—minimally invasive, maximum impact.

An Exceptional Team: Collaborate with leading engineers, clinicians, and researchers pushing the boundaries of medical robotics and neurotechnology.

Real Ownership: Join a well-funded deeptech startup backed by top investors. Shape your domain, drive strategic decisions, and grow with us.

Benefits:

• Health Insurance — We happily cover 60% of the cost.

• Meal Vouchers — €9.25 per day, We happily cover 60% of the cost.

• Transportation Reimbursement — 50% of your commuting costs covered.