Systems Engineer: Medical Device Risk & Safety Standards

ITech Consult AG; Zug; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

ITech Consult AG is seeking a Systems Engineer to ensure safety and compliance for medical and IVD devices throughout the product lifecycle. The role focuses on risk management, regulatory documentation, and cross-functional collaboration across requirements, architecture, integration and V&V.

The ideal candidate will show extensive experience in medical device system development and adherence to ISO 14971, IEC 60601-1, IEC 62304, and IEC 61508, with fluent English and German nice to have.

Qualifikationen

• Degree in Electrical/Mechanical/Software engineering, Physics or similar.
• Experience in medical device development and regulatory documentation.
• Strong understanding of risk management and quality processes.

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 corresponding documentation according to internal and external standards.
• Workpackage and task planning & reporting to project stakeholders.

Kenntnisse

Medical devices

Regulatory compliance

ISO 14971

IEC 60601-1

IEC 62304

IEC 61508

V&V

Risk management

Requirements engineering

System architecture

System integration

Usability engineering

Documentation

Ausbildung

Electrical/Mechanical/Software engineering or Physics

Tools

Regulatory documentation

Jobbeschreibung

ITech Consult AG is seeking a Systems Engineer to ensure safety and compliance for medical and IVD devices throughout the product lifecycle. The role focuses on risk management, regulatory documentation, and cross-functional collaboration across requirements, architecture, integration and V&V.

The ideal candidate will show extensive experience in medical device system development and adherence to ISO 14971, IEC 60601-1, IEC 62304, and IEC 61508, with fluent English and German nice to have.