We are seeking an experienced Risk Management Engineer (Devices) (m/f/d) to take ownership of risk analysis for both our in-house technical setups and our device product portfolio. In this role, you will be the central point of contact for risk information across different setups and teams. You will work closely with internal R&D, Systems Engineering, and Regulatory teams to make sure our internal setups and products meet safety and quality standards. You will act as the central point of contact for risk analysis, FMEA, and safety standards compliance throughout the entire lifecycle of our experimental equipment and product development.
Your responsibilities include:
Risk Analysis & FMEA Ownership
Drive and manage the risk analysis and FMEA process (design, process, and system level) for both our complex experimental setups and our laboratory equipment portfolio.
Moderate cross-functional risk assessment sessions with internal technical experts, scientists, engineers, and HSE to identify failure modes and define mitigation strategies.
Build, and maintain comprehensive Device Risk Analysis documentation and Technical Safety Documentation to ensure strict consistency and audit readiness across all projects.
Requirements & V&V Integration
Support technical teams in translating identified risks into concrete safety controls and design specifications for both internal setups and product development.
Align risk mitigations with technical testing protocols and Verification & Validation (V&V) strategies to ensure all safety-critical functions are properly verified.
Safety & Technical Compliance
Ensure compliance with relevant device safety and risk standards, utilizing ISO 12100 (Laboratory Equipment/Devices) as the leading standard, alongside other general industry guidelines.
Support the evaluation of specialized safety requirements, including chemical, gaseous, and explosion safety (ATEX considerations) related to device operations.