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Systems Engineer, Risk & Safety Standards

Gi Group · Risch, Zug, Switzerland

🌐 Remote📅 21/08/2026
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Shape the Future of Near‑Patient Diagnostics. At Roche Diagnostics, we are redefining how critical diagnostic insights reach patients—directly at the point of care. Our teams in Rotkreuz contribute to solutions that make healthcare faster, safer, and more accessible worldwide. To strengthen our Standards & Product Risks organization, we are seeking a Systems Engineer who thrives on building safe, compliant, and reliable medical and IVD systems. In this role, you will help ensure that our products meet the highest global standards for safety, performance, and regulatory compliance throughout their lifecycle. Systems Engineer, Risk & Safety Standards Your Impact As part of a cross‑functional environment—working closely with a 15‑member Standards & Risks team and project stakeholders across the company—you will: Lead FMEA activities with multidisciplinary engineering teams Identify hazards and risks within product risk management frameworks Refine system safety & reliability concepts, including functional safety for HW & SW Oversee certification‑relevant testing, including CB‑scheme documentation Maintain and update compliance documentation aligned with internal and external standards Plan workpackages, track progress, and report to project stakeholders What You Bring You are a systems‑driven engineer with a passion for safety, compliance, and robust product design. You combine technical depth with structured thinking and strong documentation discipline. Must‑Haves Degree in Electrical, Mechanical, Software Engineering, Physics, or similar 3+ years experience in product development Strong background in GMP, design controls, documentation practice, design transfer, risk management & quality compliance Fluent English (German as an advantage Your Technical Strengths Solid understanding of risk & safety standards such as ISO 14971, IEC 60601‑1, IEC 61508, IEC 62304 Experience across the systems engineering lifecycle: requirements, architecture, integration, usability, V&V Ability to quickly grasp complex technologies and navigate regulatory documentation with confidence Please apply online. For further information about the position, please contact your Gi Consultant, Mr. Dr. med. Andreas Danner (+41 44 225 41 07/ +41 76 310 760 9/ andreas.danner@.gigroup.com). Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.
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