Systems Engineer, Risk & Safety Standards

Gi Group; Risch-Rotkreuz; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Roche Diagnostics in Rotkreuz is seeking a Systems Engineer who drives safety and compliance across medical and IVD products. You will collaborate with a cross-functional team to ensure robust risk management, system safety concepts, and regulatory documentation through the lifecycle.

The role emphasizes leading FMEA, identifying hazards, maintaining compliance, and delivering clear work plans and reports to stakeholders, with fluent English and German language advantage.

Qualifikationen

• 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).

Aufgaben

• 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
• Maintain and update compliance documentation aligned with internal and external standards
• Plan workpackages, track progress, and report to project stakeholders

Kenntnisse

FMEA Leadership

Risk Management

Documentation Discipline

Regulatory Compliance

System Safety

GMP Knowledge

Ausbildung

Electrical Engineering

Mechanical Engineering

Software Engineering

Physics

Jobbeschreibung

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
• 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.

• 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