System V&V Engineer

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…