Hybrid Systems Engineer – Risks & Safety Standards

Flexsis; Risch-Rotkreuz; Hybrid; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

Roche Diagnostics in Rotkreuz seeks a reliable and motivated Systems Engineer in Risks and Safety Standards (m/f/d) for a 12-month assignment with a high likelihood of extension. 50% on-site presence required with up to 20% travel to Mannheim, Germany. Start on 01.10.2026; latest start 01.01.2027.

GMP experience and design controls are required. Responsibilities include organizing FMEA, updating safety concepts for HW/SW, overseeing tests and CB reports, and ensuring documentation aligns with

Qualifikationen

• More than 3 years experience in product development.
• GMP experience and knowledge of Design controls.
• Good documentation practice and design transfer experience.
• Risk management and quality process compliance.

Aufgaben

• Organize and execute failure mode and effects analysis with a team of engineers.
• Identify hazards and risks in context of product risk management.
• Revise HW & SW system safety and reliability concepts, incl. functional safety.
• Oversee execution and documentation of tests within the certification board scheme (CB report).
• Update and provide documentation according to internal and external standards.
• Work package and task planning & reporting to project stakeholders.

Kenntnisse

Product development experience

Risk management

Documentation practices

Ausbildung

Bachelor of Electrical/Mechanical/Software Engineering or Physics

Jobbeschreibung

Roche Diagnostics in Rotkreuz seeks a reliable and motivated Systems Engineer in Risks and Safety Standards (m/f/d) for a 12-month assignment with a high likelihood of extension. 50% on-site presence required with up to 20% travel to Mannheim, Germany. Start on 01.10.2026; latest start 01.01.2027.

GMP experience and design controls are required. Responsibilities include organizing FMEA, updating safety concepts for HW/SW, overseeing tests and CB reports, and ensuring documentation aligns with