Systems Engineer Risks and Safety Standards

ITech Consult AG; Risch-Rotkreuz; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

ITech Consult AG in Rotkreuz seeks a Systems Engineer specializing in medical device risk and safety standards to ensure safety and performance across the product lifecycle. In the Standards & Product Risks team, you will navigate regulatory documentation for critical risk and safety standards.

The candidate should have extensive medical device system development experience, proficiency in ISO 14971, IEC 60601-1, IEC 61508, IEC 62304, and demonstrate a strong background in risk management and

Qualifikationen

• Medical device system development with regulatory compliance.
• Experience with ISO 14971, IEC 60601-1, IEC 61508, IEC 62304.
• Lifecycle activities from requirements to V&V.
• Strong documentation and risk management.

Aufgaben

• Organize and perform 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

Systems engineering

Risk management

V&V

Functional safety

Regulatory documentation

Quality process compliance

GMP experience

Design controls

Good documentation practice

Design transfer

Fluent English

German (Nice to have)

Ausbildung

Electrical/Mechanical/Software engineering, Physics

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.