System V&V Engineer M H/F - 75

At Robeauté we are developing a really small microrobot for novel therapies in hard-to-reach areas of the body.

Designed specifically for the brain, at the service of neurosurgeons, our microrobot will be able to freely navigate in other complex regions of the body to perform biopsies, collect precise anatomically localized data and deliver therapies on site, at the right dosage.

We are accompanying a major shift from robotic surgery to microrobotic surgery, for greater precision, better results and bold new therapies to tackle global diseases affecting more than a billion people worldwide.

Our microrobot will light a spark in the minds of medical practitioners and scientists around the world, allowing them to imagine and create more effective treatments, to be delivered locally.

We are a pluridisciplinary and multicultural team of passionate, skilled, supportive and creative people, at the crossroads of microrobotics, engineering and medicine. We work with phenomenal medical centers and university labs in Europe and the United States.

Our team is growing and we are constantly on the lookout for highly-talented individuals. Working with us means working on something that has never been done before, so you will be challenged - and you will be supported.

We are team players, with both classical and atypical backgrounds, so unconventional thinking is welcome and good communication skills are a must.

We are based in Paris, France.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 a SystemV&V Engineer to define and lead robustsystemverificationstudiesacross our medical device portfolio, ensuring regulatory compliance and engineering excellence.

Whatyou'lldo

SystemProduct/DeviceVerification

- Collaboratetothe definition and execution ofthesystem-level verification strategies, ensuring full traceability to user and design requirements in compliance withorQuality 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.,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 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 atechnical leaderwithintheSystemteam, guiding integration andverification ofbest practices across projects.

- Provide training and mentorship in 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.

- Continuouslymonitor industry trends and evolving standards to adapt and improve internaldesign controlprocesses.

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