System V&V Engineer (M/F/X)

Robeaute; Paris; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

An innovative medical technology firm in France, specializing in neurosurgery microrobots, is seeking a System V&V Engineer to lead verification studies. Applicants should have a strong background in ISO and FDA standards, with over 5 years in the medical device sector. This role involves cross-functional collaboration, ensuring compliance across the product lifecycle while participating in innovative projects that impact patient care.

Prestations

Alan Health Insurance

Meal Vouchers

Transportation Reimbursement

Qualifications

• 5+ years of experience in system integration, verification, and design control within the medical device industry.
• Proven ability to develop and maintain verification documentation.

Responsabilités

• Define and lead robust system verification studies across medical device portfolio.
• Collaborate with cross-functional teams to analyze test results and identify root causes.
• Act as a technical leader within the team, guiding integration and verification best practices.

Connaissances

ISO 13485

ISO 14971

FDA 21 CFR 820

ALM tools

Analytical skills

Excellent communication

Formation

Bachelor’s or Master’s degree in Electrical Engineering

5+ years of experience in medical device industry

Outils

Jama

Matrix Requirements

Description du poste

Robeautéis redefining the future of neurosurgery with self-propelled microrobots designed to navigate the human brain with unprecedented precision. Our technology makes it possible to reach deep brain regions that were previously inaccessible, without invasive surgery.

We’vedeveloped microrobots capable of travelling inside the brain to collect biopsies, deliver cancer drugs, and implant electrodes for neurological treatments.

Since our founding in 2017,we’vefiled 50+ patents and successfully tested our technology in living animals, with human clinical trials targeted for 2026. We recently raised €27M in Series A funding from Plural, Cherry Ventures, Kindred Ventures, andBrainlab, fueling our next phase of growth.

Now, as we scale, we are looking for aSystemV&V Engineerto define and lead robustsystemverificationstudiesacross our medical device portfolio, ensuring regulatory compliance and engineering excellence.

Whatyou’lldo

SystemProduct/DeviceVerification

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

• Develop andleadfunctional andsafety testingaccordingto thesystemverificationstrategy, ensuring coverage and alignment with design inputsand regulatory standards (e.g.,Biocompatibility followingISO 10993 series,Transport and shelf-life validation followingISO 11607,Systemfunctionalintegrationandrobustness tests)

• Collaborate withR&DandProductteamsin thedefinitionofverificationstudiesthey ownon thehardware and softwarecomponents.(e.g.,based on ISO60601-1for electrical safety,62304for medical devicesoftware,IEC80001-5-1andIEC 82304-1for cybersecurity).

• 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 the Design 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 atechnical leaderwithintheSystemteam, guiding integration andverification ofbest practices across projects.

• Providetraining and mentorshipin her/his domain to engineers, project leads, and technical managers on regulatory expectations and engineering excellence.

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

• Continuouslymonitorindustry trends and evolving standardsto adapt and improve internaldesign controlprocesses.

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

Technical Skills

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

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

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:

Alan Health Insurance— One of France's most innovative health insurance providers. 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.