Systems Engineer Risks and Safety Standards (m/f/d) Vollzeit NEU

Jobdescription

We are looking for a dedicated, safety-minded Systems Engineer Risks and Safety Standards (m/f/d) to strengthen an international Standards & Product Risks team for our client, a leader in the medical device and in-vitro diagnostics industry based in Rotkreuz.

In the field of Near Patient Care, you will play a key role in shaping the future of diagnostics directly at the patient’s side. You will be passionately committed to designing reliable, high-performance products and maintaining compliance throughout the entire product lifecycle. Working within a cross-functional environment, you will ensure medical and IVD devices meet the highest safety, functional, and regulatory standards.

General Information

• Start Date: 01.10.2026 (Latest possible start date: 01.01.2027)

• Duration: 1 year (extension very likely)

• Workplace: Rotkreuz

• Workload: 100%

• Home Office: Yes (minimum 50% presence required on site)

• Travel Activity: Yes, up to 20% (mostly within Europe)

Tasks & Responsibilities

• Risk Analysis & Execution: Organize and execute Failure Mode and Effects Analysis (FMEA) in close collaboration with multidisciplinary engineering teams to identify hazards and risks within product risk management.

• Safety & Reliability Concepts: Revise and optimize hardware and software system safety and reliability concepts, including functional safety architectures.

• Certification & Testing Oversight: Oversee the execution and documentation of tests within the certification body scheme (CB report) to ensure global compliance.

• Documentation & Standards Maintenance: Update, author, and maintain system documentation in full alignment with internal quality processes and external regulatory standards.

• Project Planning & Stakeholder Reporting: Lead workpackage and task planning while regularly reporting progress, risk updates, and safety insights to key project stakeholders.

Qualifications & Requirements (Must-Haves)

• Education: Degree in Electrical, Mechanical, or Software Engineering, Physics, or a related technical field.

• Product Development Experience: Min. 3 years of applied experience in system development and engineering across the product lifecycle.

• Regulatory & Quality Standards: Proven experience with Design Controls, Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), design transfer, risk management, and quality process compliance.

• Language Skills: Fluent in English (spoken and written).

Desirable Skills (Nice-to-Haves)

• Standards Expertise: Comprehensive understanding of critical risk and safety standards, including ISO 14971, IEC 60601-1, IEC 61508, and IEC 62304.

• Multilingual Capability: Proficiency in German is a strong plus.