System V&V Engineer

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 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 aSystemV&V Engineerto define and lead robustsystem designverificationstudiesacross our medical device portfolio, ensuring regulatory compliance and engineering excellence.

Whatyou’lldo

SystemProduct/DeviceVerification

• Define the system-level verification strategies, ensuring full traceability to user and design requirements in compliance withourQuality Management Systemanddesign controlproceduresbased onISO 13485,ISO 14971and FDArules andguidelines.

• Develop andleadfunctional andsafety testingaccordingto thesystemverificationstrategy, ensuring coverage and alignment with design inputsand regulatory standards (e.g.,compliance with ISO 10993 series, ISO 11607,Systemfunctionalintegrationandrobustness tests)

• Ensure that verificationstudies on thehardware and softwarecomponents (e.g.,based on ISO60601-1for electrical safety,62304for medical device software,IEC80001-5-1andIEC 82304-1for cybersecurity) owned by R&D team are integrated in the system verification strategy.

• Collaborate with cross-functional teams toanalyze testresults,identifyroot causes of system issues,define corrective and preventive actions.

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

Cross-Functional Collaboration

• Collaborate closely withsystem,softwareandhardwareengineering teamsto ensure seamless integration of all subsystems into a unified, high-performance product.

• Interface withQuality Assurance, Regulatory Affairs, and Clinical teamsto ensureverificationdeliverables meet regulatory submission and audit requirements.

• Participate indesign reviews,risk assessments, and usability evaluations,providingsystem-level insight into potential design or integration issues.

• Contribute tocontinuous improvementof verification processes, test automation strategies, and system-level test methodologies.

Training & Process Leadership

• Act as a leaderwithintheSystemteam, guiding integration ofbest practices and alignment across projects regarding system verification testing.

• Providetraining and mentorshipto engineers, project leads, and technical managers on regulatory expectations about design verification testing.

• Supportcross-functional alignmenton technical decisions, risk mitigation strategies, and verification priorities.

• Continuouslymonitorindustry trends and evolving standardsto adapt and improve internaldesign controlprocesses, with specific attention to testing procedures.

• Promote a culture ofrigor, traceability, andregulatory disciplineacross the product lifecycle.

Requirements

Technical Skills

• Working knowledge ofISO 13485,ISO 14971,ISO 10993,ISO11607andFDA 21 CFR 820.

• Hands-on experience withALM tools(e.g., Jama, MatrixRequirements),statistical analysis.

• Familiarity withISO 60601-1 and collaterals standards, ISO 62304,andcybersecurity standards(e.g., FDA premarket guidance)isa plus.

Personal Attributes

• Analytical, methodical, and rigorous, with a strongprocessorientation.

• 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 inElectrical Engineering, Biomedical Engineering, Systems Engineering,or related field.

• 5+ years of experiencein system integration, verification, and design control within themedical device industry.

• Proven ability to develop andmaintainverificationdocumentation(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 over1 million patientswith 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.