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

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.