Systems Engineer Risks and Safety Standards
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Job description
* 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.
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