> Markdown version of [/jobs/ext/4108001-system-engineer-h-f](https://www.wearedevelopers.com/jobs/ext/4108001-system-engineer-h-f). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # System Engineer H/F - **Company:** Bienvenue Chez Robeauté - **Location:** Paris, France - **Contract:** Permanent contract - **Skills:** Adobe InDesign, Systems Engineering, Failure Mode Effects Analysis, Requirements Management, Software Requirements Analysis, Verification and Validation (Software), Systems Architecture, Jama (Software) - **Published:** October 14, 2026 - **Apply:** https://www.hellowork.com/fr-fr/emplois/84442703.html ## About the Role 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:Health Insurance - 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.Technical Skills- Strong knowledge of medical device design controls, ISO 13485, ISO 14971, and applicable FDA quality-system requirements.- Familiarity with multidisciplinary product development involving software, electronics, mechanics, robotics, and/or disposable components.- Experience with requirements management tools such as Jama or Matrix Requirements; familiarity with systems modeling methods is a plus.- Ability to apply structured analysis methods such as FMEA, fault tree analysis, event tree analysis.Personal Attributes- Systems thinker who can move comfortably between the complete product, subsystem details, and clinical use context.- Analytical, methodical, and rigorous, with the judgment to distinguish between critical issues.- Clear communicator and facilitator, able to align specialists with different technical perspectives and priorities.- Pragmatic, proactive, and comfortable taking ownership in a multidisciplinary, fast-paced environment., 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., Strong knowledge of medical device design controls, ISO 13485, ISO 14971, and applicable FDA quality-system requirements. - Familiarity with multidisciplinary product development involving software, electronics, mechanics, robotics, and/or disposable components. - Experience with requirements management tools such as Jama or Matrix Requirements; familiarity with systems modeling methods is a plus. - Ability to apply structured analysis methods such as FMEA, fault tree analysis, event tree analysis. Personal Attributes - Systems thinker who can move comfortably between the complete product, subsystem details, and clinical use context. - Analytical, methodical, and rigorous, with the judgment to distinguish between critical issues. - Clear communicator and facilitator, able to align specialists with different technical perspectives and priorities. - Pragmatic, proactive, and comfortable taking ownership in a multidisciplinary, fast-paced environment. ## Description Now, as we scale, we are looking for a System Engineer to ensure that our complex medical devices are developed as coherent, safe, effective, and verifiable systems. You will translate clinical and user needs into clear system requirements and architectures, maintain control of interfaces and traceability, manage risks and guide integration across software, electronics, mechanics, robotics, and disposables. What you'll do System Definition and Requirements - Translate clinical, user, business, regulatory, and operational needs into clear, consistent, and verifiable system requirements. - Specify and manage interfaces between software, electronics, robotics, , accessories, and external systems. - Maintain end-to-end traceability between stakeholder needs, system and subsystem requirements, risk definition and controls, design outputs, and verification and validation evidence. - Assess requirement quality, completeness, feasibility, and testability, and drive resolution of gaps, ambiguities, and conflicts. System Architecture and Technical Decision-Making - Evaluate the impact of design changes across the complete system and ensure that dependencies, interfaces, requirements, and risks remain controlled. - Identify cross-functional technical issues early and coordinate structured resolution with the relevant engineering owners. Risk Management and Design Controls - Integrate risk management into system design in collaboration with Quality, Clinical, and engineering teams, in accordance with ISO 14971 and the company Quality Management System. - Contribute system-level expertise to hazard analyses, use related risk analyses, fault analyses, and definition of risk control measures. - Ensure consistency between requirements, architecture, risk controls, usability engineering, and verification and validation activities throughout the product lifecycle. - Participate in design reviews and support the preparation of clear, audit-ready deliverables for the Design History File. Integration, Verification, and Validation Support - Work closely with V&V teams to ensure that system requirements are objectively verifiable and that verification coverage is complete and risk based. - Support investigation of integration and system-level failures by connecting evidence across disciplines and coordinating root-cause analysis. - Provide system level input to design validation, usability validation, clinical activities, and design transfer to manufacturing. Cross-Functional Collaboration and Process Leadership - Facilitate requirement reviews, architecture reviews, interface reviews, and technical decision forums, ensuring clear ownership and follow-up. - Promote systems thinking, disciplined documentation, and constructive technical challenge across development teams. - Improve system engineering methods, templates, tools, and lifecycle processes, and mentor colleagues in their practical application.