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.