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

Paris, Ile-de-France, France -

Full Time

Start Date

Immediate

Expiry Date

25 Jan, 26

Salary

0.0

Posted On

27 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

ISO 13485, ISO 14971, ISO 10993, ISO 11607, FDA Regulations, ALM Tools, Static Analysis, ISO 60601-1, ISO 62304, Cybersecurity Standards, Analytical Skills, Communication Skills, Process Orientation, Documentation, Multidisciplinary Collaboration, Risk Mitigation

Industry

Medical Equipment Manufacturing

Description

Robeauté 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. We’ve developed 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’ve filed 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, 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 verification studies across our medical device portfolio, ensuring regulatory compliance and engineering excellence. What you’ll do System Product/Device Verification 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 and lead functional and safety testing according to the system verification strategy, ensuring coverage and alignment with design inputs and regulatory standards (e.g., Biocompatibility following ISO 10993 series, Transport and shelf-life validation following ISO 11607, System functional integration and robustness tests) Collaborate with R&D and Product teams in the definition of verification studies they own on the hardware and software components. (e.g., based on ISO 60601-1 for electrical safety, 62304 for medical devicesoftware, IEC 80001-5-1 and IEC 82304-1 for cybersecurity). 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 technical leader within the System team, guiding integration and verification of best practices across projects. Provide training and mentorship in her/his domain to engineers, project leads, and technical managers on regulatory expectations and engineering excellence. Support cross-functional alignment on technical decisions, risk mitigation strategies, and verification priorities. Continuously monitor industry trends and evolving standards to adapt and improve internal design control processes. Promote a culture of rigor, traceability, and regulatory discipline across the product lifecycle. Technical Skills Strong knowledge of ISO 13485, ISO 14971, ISO 10993, ISO 11607 and FDA 21 CFR 820. Hands-on experience with ALM tools (e.g., Jama, Matrix Requirements), static analysis. Familiarity with ISO 60601-1 and collaterals standards, ISO 62304, and cybersecurity standards (e.g., FDA premarket guidance) is a plus. Personal Attributes Analytical, methodical, and rigorous, with a strong process orientation. 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 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). 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.

Responsibilities

The System V&V Engineer will define and lead robust system verification studies across the medical device portfolio, ensuring regulatory compliance and engineering excellence. This role involves collaboration with cross-functional teams to analyze test results and support validation activities.