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

<p>Robeauté&nbsp;is 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.&nbsp;</p><p>We’ve&nbsp;developed microrobots capable of travelling inside the brain to collect biopsies, deliver cancer drugs, and implant electrodes for neurological treatments.&nbsp;</p><p>Since our founding in 2017,&nbsp;we’ve&nbsp;filed 50+ patents and successfully tested our technology in living animals, with human clinical trials targeted for 2026/2027. We recently raised €27M in Series A funding from Plural, Cherry Ventures, Kindred Ventures, and&nbsp;Brainlab, fueling our next phase of growth.&nbsp;</p><p>Now, as we scale, we are looking for a System&nbsp;V&amp;V Engineer to define and lead robust&nbsp;system&nbsp;verification&nbsp;studies&nbsp;across our medical device portfolio, ensuring regulatory compliance and engineering excellence.&nbsp;</p><p>&nbsp;</p><p><strong>What&nbsp;you’ll&nbsp;do&nbsp;</strong></p><p><strong>System&nbsp;Product/Device&nbsp;Verification&nbsp;</strong></p><ul><li>Collaborate&nbsp;to&nbsp;the definition and execution of&nbsp;the&nbsp;system-level verification strategies, ensuring full traceability to user and design requirements in compliance with&nbsp;our&nbsp;Quality Management System&nbsp;and&nbsp;design control&nbsp;procedures&nbsp;based on&nbsp;ISO 13485,&nbsp;&nbsp;ISO 14971&nbsp;and FDA&nbsp;rules and&nbsp;guidelines.&nbsp;</li></ul><ul><li>Develop and&nbsp;lead&nbsp;functional and&nbsp;safety testing&nbsp;according&nbsp;to the&nbsp;system&nbsp;verification&nbsp;strategy, ensuring coverage and alignment with design inputs&nbsp;and regulatory standards (e.g.,&nbsp;Biocompatibility following&nbsp;ISO 10993 series,&nbsp;Transport and shelf-life validation following&nbsp;ISO 11607,&nbsp;System&nbsp;functional&nbsp;integration&nbsp;and&nbsp;robustness tests)&nbsp;</li></ul><ul><li>Collaborate with&nbsp;R&amp;D&nbsp;and&nbsp;Product&nbsp;teams&nbsp;in the&nbsp;definition&nbsp;of&nbsp;verification&nbsp;studies&nbsp;they own&nbsp;on the&nbsp;hardware and software&nbsp;components.&nbsp;(e.g.,&nbsp;based on ISO&nbsp;60601-1&nbsp;for electrical safety,&nbsp;62304&nbsp;for medical devicesoftware,&nbsp;IEC&nbsp;80001-5-1&nbsp;and&nbsp;IEC 82304-1&nbsp;for cybersecurity).&nbsp;</li></ul><ul><li>Collaborate with cross-functional teams to&nbsp;analyze test&nbsp;results,&nbsp;identify&nbsp;root causes of system issues,&nbsp;define corrective and preventive actions.&nbsp;</li></ul><ul><li>Support validation and design transfer activities, ensuring the integrity of verification evidence in the&nbsp;Design History File (DHF).&nbsp;</li></ul><ul><li>Cross-Functional Collaboration&nbsp;</li></ul><ul><li>Collaborate closely with&nbsp;system,&nbsp;software&nbsp;and&nbsp;hardware&nbsp;engineering teams&nbsp;to ensure seamless integration of all subsystems into a unified, high-performance product.&nbsp;</li></ul><ul><li>Interface with&nbsp;Quality Assurance, Regulatory Affairs, and Clinical teams&nbsp;to ensure&nbsp;verification&nbsp;deliverables meet regulatory submission and audit requirements.&nbsp;</li></ul><ul><li>Participate in&nbsp;design reviews,&nbsp;risk assessments, and usability evaluations,&nbsp;providing&nbsp;system-level insight into potential design or integration issues.&nbsp;</li></ul><ul><li>Contribute to&nbsp;continuous improvement&nbsp;of verification processes, test automation strategies, and system-level test methodologies.&nbsp;</li></ul><p>&nbsp;</p><p><strong>Training &amp; Process Leadership</strong>&nbsp;</p><ul><li>Act as a&nbsp;technical leader&nbsp;within&nbsp;the&nbsp;System&nbsp;&nbsp;team, guiding integration and&nbsp;verification of&nbsp;best practices across projects.&nbsp;</li></ul><ul><li>Provide training and mentorship in her/his domain to engineers, project leads, and technical managers on regulatory expectations and engineering excellence.&nbsp;</li></ul><ul><li>Support&nbsp;cross-functional alignment&nbsp;on technical decisions, risk mitigation strategies, and verification priorities.&nbsp;</li></ul><ul><li>Continuously&nbsp;monitor industry trends and evolving standards to adapt and improve internal&nbsp;design control&nbsp;processes.&nbsp;</li></ul><ul><li>Promote a culture of rigor, traceability, and regulatory discipline across the product lifecycle.&nbsp;</li></ul> <p>&nbsp;T<strong>echnical Skills</strong>&nbsp;</p><ul><li>Strong knowledge of &nbsp;ISO 13485, ISO 14971, ISO 10993,&nbsp;ISO&nbsp;11607&nbsp;and FDA 21 CFR 820.&nbsp;</li></ul><ul><li>Hands-on experience with ALM tools (e.g., Jama, Matrix&nbsp;Requirements), static analysis.&nbsp;</li></ul><ul><li>Familiarity with&nbsp;ISO 60601-1 and collaterals standards, ISO 62304,&nbsp;and cybersecurity standards (e.g., FDA premarket guidance)&nbsp;is&nbsp;a plus.&nbsp;</li></ul><p><strong>Personal Attributes</strong>&nbsp;</p><ul><li>Analytical, methodical, and rigorous, with a strong&nbsp;process&nbsp;orientation.&nbsp;</li></ul><ul><li>Excellent communicator and trainer, able to influence cross-functional teams.&nbsp;</li></ul><ul><li>Pragmatic and proactive, with a commitment to documentation and compliance.&nbsp;</li></ul><ul><li>Comfortable working in a multidisciplinary and fast-paced environment.&nbsp;</li></ul><p><strong>Education and Experience</strong>&nbsp;</p><ul><li>Bachelor’s or Master’s degree in&nbsp;Electrical Engineering, Biomedical Engineering, Systems Engineering,&nbsp;or related field.&nbsp;</li></ul><ul><li>5+ years of experience&nbsp;in system integration, verification, and design control within the&nbsp;medical device industry.&nbsp;&nbsp;</li></ul><ul><li>Proven ability to develop and&nbsp;maintain&nbsp;verification&nbsp;documentation&nbsp;(V&amp;V plans, test protocols, reports, and traceability).&nbsp;</li></ul> <p><strong>A Mission That Matters:</strong>&nbsp;Join a team developing life-changing technology. Our microrobots have the potential to help over&nbsp;<strong>1 million patients</strong>&nbsp;with neurological conditions.</p><p><strong>World-First Innovation:</strong>&nbsp;Work on pioneering microrobots that navigate the brain for diagnosis and treatment—minimally invasive, maximum impact.</p><p><strong>An Exceptional Team:</strong>&nbsp;Collaborate with leading engineers, clinicians, and researchers pushing the boundaries of medical robotics and neurotechnology.</p><p><strong>Real Ownership:</strong>&nbsp;Join a well-funded deeptech startup backed by top investors. Shape your domain, drive strategic decisions, and grow with us.</p><p><strong>Benefits:</strong></p><p><strong>Alan Health Insurance</strong>&nbsp;— One of France's most innovative health insurance providers. We happily cover 60% of the cost.</p><p><strong>Meal Vouchers</strong>&nbsp;— €9.25 per day, We happily cover 60% of the cost.</p><p><strong>Transportation Reimbursement</strong>&nbsp;— 50% of your commuting costs covered.</p>