System Engineer 80 - 100 % (w/m/d)

Hamilton Medical, a global leader with more than four decades of experience in mechanical ventilation, creates Intelligent Ventilation solutions that support clinicians during critical moments. Their ventilators are deployed in intensive‑care units, emergency transport, and MRI settings, serving adult, pediatric and neonatal patients worldwide. As a System Engineer you will join a multinational team that directly influences the safety and effectiveness of respiratory care for patients around the globe. In this role you will work closely with cross‑functional stakeholders to capture operational problems, clarify assumptions and define the intended product value. You will derive and manage system requirements, ensure traceability to system behaviour, and help shape the functional architecture. Collaboration with software, hardware, mechanical, clinical and usability experts will be essential to evaluate and realise technical solutions for the physical architecture. You will also plan and support integration, verification and validation activities while contributing to regulatory compliance through risk management, reliability analysis, documentation and evidence generation. Continuous improvement of engineering processes, MBSE methods and toolchains is part of the daily routine. The position requires a B.Sc. or M.Sc. in Engineering, Computer Science, Systems Engineering or a related technical field. You must have proven experience in medical‑device development or another regulated industry and a solid understanding of product‑development lifecycles. Core knowledge of systems engineering, requirements engineering, architecture development and traceability is mandatory, as is fluency in English at a professional level. Familiarity with the relevant regulations and standards, MDR, FDA, ISO 13485, ISO 14971 and IEC 60601‑1, is also required. Additional assets include German language skills, experience with model‑based systems engineering (MBSE) methods and toolchains, and hands‑on work with ALM or requirements‑lifecycle management tools such as Codebeamer. An interest in digital engineering, AI‑assisted workflows and the continuous refinement of engineering methods is welcomed. Hamilton offers a cooperative, innovative environment with modern working conditions, open communication at eye level and ample opportunities for professional growth within its Swiss headquarters and worldwide locations. What the role asks for: - B.Sc. or M.Sc. in Engineering, Computer Science, Systems Engineering or related field - Experience in medical device development or other regulated industry - Knowledge of systems engineering, requirements engineering and architecture traceability - Fluent English (professional level) - Knowledge of MDR, FDA, ISO 13485, ISO 14971, IEC 60601‑1 standards - German language skills (advantage) - Experience with MBSE methods and toolchains (nice-to-have) - Experience with ALM/requirements lifecycle tools such as Codebeamer (nice-to-have)