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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # System V&V Engineer - **Company:** Robeaute - **Location:** Paris, France - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Adobe InDesign, Systems Engineering, Automation of Tests, Computer Engineering, Verification and Validation (Software), Systems Integration, Jama (Software), System-level Testing - **Published:** July 26, 2026 - **Apply:** https://fr.indeed.com/viewjob?jk=cb95e33a68667e7b ## About the Role * Working 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), statistical 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., * 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) and execute design verification strategies. ## Description 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., * 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 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, with specific attention to testing procedures. * Promote a culture of rigor, traceability, and regulatory discipline across the product lifecycle. ## Related Videos - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [Times of (climate) crisis - How and why sustainable software is a must!](https://www.wearedevelopers.com/videos/988-times-of-climate-crisis-how-and-why-sustainable-software-is-a-must) - [Agile work at CARIAD – Creating a customer web application for controlling the vehicle ](https://www.wearedevelopers.com/videos/200-agile-work-at-cariad-creating-a-customer-web-application-for-controlling-the-vehicle) - [Reporting Active Exploits in 24 Hours: Are You Ready for the CRA?](https://www.wearedevelopers.com/videos/100248-reporting-active-exploits-in-24-hours-are-you-ready-for-the-cra) - [Automated Driving - Why is it so hard to introduce](https://www.wearedevelopers.com/videos/628-automated-driving-why-is-it-so-hard-to-introduce) - [Kettle and Pot or Peas in a Pod? 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