Systems Engineer - Risks & Safety for Medical Devices

Work Selection AG; Rotkreuz; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

On-site parking

Staff restaurants

Mobility discounts

Onboarding program

Professional development

Zusammenfassung

Roche Diagnostics in Rotkreuz seeks a Systems Engineer Risks and Safety for a 12-month assignment with a high probability of extension. You will help ensure safety and performance of medical and IVD devices across the lifecycle, focusing on ISO 14971, IEC 60601-1, IEC 61508 and IEC 62304.

As part of the Standards & Product Risks team, you will drive risk assessments, document CB tests and maintain compliance, collaborating with engineers to deliver reliable, safe products on a global stage.

Qualifikationen

• Degree in Electrical/Mechanical/Software Engineering, Physics, or similar.
• More than 3 years of experience in product development.
• GMP experience, experience with design controls, good documentation practice, design transfer, risk management, and quality process compliance.
• Fluent English.
• Familiarity with ISO 14971, IEC 60601-1, IEC 61508 and IEC 62304 is preferred.

Aufgaben

• Organize and execute failure mode and effects analysis with a team of engineers.
• Identify hazards and risks in the 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 corresponding documentation according to internal and external standards.
• Workpackage and task planning & reporting to project stakeholders.

Kenntnisse

GMP experience

Design controls

Risk management

Documentation practice

Quality process compliance

Fluent English

3+ years product development

Ausbildung

Electrical/Mechanical/Software Engineering or Physics

Jobbeschreibung

Roche Diagnostics in Rotkreuz seeks a Systems Engineer Risks and Safety for a 12-month assignment with a high probability of extension. You will help ensure safety and performance of medical and IVD devices across the lifecycle, focusing on ISO 14971, IEC 60601-1, IEC 61508 and IEC 62304.

As part of the Standards & Product Risks team, you will drive risk assessments, document CB tests and maintain compliance, collaborating with engineers to deliver reliable, safe products on a global stage.