Systems Engineer Risks and Safety Standards

* IT - Quality Management

* Contracting

* Teilzeit, 100%

* 01.10.2026 - 31.09.2027

* Product development, GMP, Design Controls

#### **Hard Facts** ####

* **Start Date:** 01.10.2026 latest 01.01.2027

* **Duration:** 12 months

* **Extension:** Very likely

* **Workload:** 100%

* **Location:** Rotkreuz, Switzerland & Mannheim, Germany

* **Home Office:** Hybrid, minimum 50% onsite presence required

* **Travel:** Up to 20% to Mannheim, Germany

* **Work Model:** Hybrid

### **Responsibilities** ###

* Lead and facilitate Failure Mode and Effects Analysis (FMEA) workshops with cross-functional engineering teams

* Identify hazards and evaluate risks within the product risk management process

* Review and update hardware and software safety and reliability concepts, including functional safety aspects

* Oversee test execution and documentation required for certification board (CB) reports

* Maintain and update technical documentation in accordance with internal and external standards

* Plan, coordinate, and report work packages and project activities to stakeholders

### **Must-Have Qualifications** ###

* Degree in Electrical Engineering, Mechanical Engineering, Software Engineering, Physics, or a related field

* More than 3 years of experience in product development

* Experience in GMP-regulated environments, including

* Design Controls

* Good Documentation Practice (GDP)

* Design Transfer

* Risk Management

* Quality Process Compliance

* Fluent English communication skills

### **Nice-to-Have** ###

* German language skills

### **Ideal Candidate Profile** ###

The ideal candidate brings hands-on experience across the complete systems engineering lifecycle, including requirements engineering, system architecture, integration, usability engineering, and verification & validation (V&V). A strong track record in medical devices or IVD products, combined with expertise in risk management, safety/reliability engineering, and regulatory compliance, will be key to success in this role.