Systems Engineer Risks and 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

Systems Engineer Risks and Safety Standards: Product Development / Critical Risk /Safety Standards / documentation / Medical Devices / IVD devices / quality process compliance / English / German

Background

In the field of Near Patient Care, we are shaping the future of diagnostics directly at the patient's side.

We are looking for a systems engineer who is passionately committed to designing reliable products and to maintaining compliance throughout the product lifecycle. As a part of our Standards & Product Risks team, you will ensure the safety and performance of our medical and IVD devices.

The Perfect Candidate

possesses extensive expertise in medical device system development, with a deep understanding of compliance for critical risk and safety standards, including ISO 14971, IEC 60601-1, IEC 61508, and IEC 62304. They offer comprehensive experience across the systems engineering lifecycle-from requirements engineering to architecture, system integration, usability engineering and verification & validation (V&V). Furthermore, they demonstrate proficiency in risk management, safety/reliability engineering and product lifecycle management, alongside a proven ability to rapidly master complex technologies and navigate rigorous regulatory documentation.

Tasks & Responsibilities

• 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

Must Haves

• A degree in Electrical/Mechanical/Software engineering, Physics or similar
• More than 3 years experience in product development
• GMP experience, experience with Design controls, good documentation practice, design transfer, risk management and quality process compliance
• Fluent English

Nice to Haves

• German

Reference Nr.: 925173
Rolle: Systems Engineer
Industrie: Pharma
Location: Rotkreuz
Pensum: 100%
Start: 01.10.2026 Latest start date(01.01.2027)
Duration: 12 + Months
Deadline: 28/08/2026

About us:

ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.