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Risk Management Engineer – Devices
NVision Quantum Technologies. Drive and manage risk analysis and FMEA processes at design, process, and system levels .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in risk analysis, FMEA processes, and technical safety documentation for complex devices, ensuring compliance with ISO standards and effective collaboration across multidisciplinary teams.
Highest-signal resume keywords
Risk ManagementFMEA OwnershipTechnical Safety DocumentationISO 12100 ComplianceModeration and Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Risk AnalysisFMEATechnical Safety DocumentationDevice Risk StandardsVerification and Validation StrategiesIterative Hardware DevelopmentV-Model Product Development LifecycleISO 14971 FamiliarityExplosion Safety EvaluationHazardous Substance Handling
Soft Skills
Moderation SkillsMediation SkillsCommunication Skills
Industry Keywords
Medical DevicesLaboratory EquipmentAerospaceATEXIECEx
About the role
Key responsibilities & impact- Drive and manage risk analysis and FMEA processes at design, process, and system levels
- Own risk analysis for complex experimental setups and laboratory equipment products
- Moderate cross-functional risk assessment sessions with technical experts, scientists, engineers, and HSE
- Identify failure modes and define mitigation strategies
- Build and maintain Device Risk Analysis and Technical Safety Documentation
- Ensure documentation consistency and audit readiness across projects
- Translate identified risks into safety controls and design specifications
- Align risk mitigations with technical testing protocols and Verification & Validation strategies
- Ensure safety-critical functions are properly verified
- Ensure compliance with device safety and risk standards, especially ISO 12100
- Support evaluation of chemical, gaseous, and explosion safety requirements, including ATEX considerations
- Collaborate with R&D, Systems Engineering, and Regulatory teams throughout equipment and product lifecycles
Requirements
What you’ll need- B.Sc., M.Sc., or Ph.D. in Engineering, Physics, or a related technical discipline
- 4+ years of professional experience in risk management, systems engineering, or quality/regulatory engineering
- Experience ideally in medical devices, laboratory equipment, or aerospace/aerotech
- Demonstrated experience owning FMEA and Technical Safety Documentation for complex physical devices
- Strong understanding of device risk standards, particularly ISO 12100
- Familiarity with iterative hardware development, the V-Model product development lifecycle, and ISO 14971 is a strong plus
- Excellent moderation, mediation, and communication skills in English
- Ability to facilitate technical risk alignment across multidisciplinary teams
- German is a big plus
- Prior experience with explosion safety (ATEX/IECEx) or handling hazardous, volatile, or flammable substances within device systems is a strong plus
- Requirement to work onsite or hybrid, at least 2 to 3 days per week onsite at the Ulm office
Benefits
Comp & perks- Attractive compensation package, including a competitive base salary and stock options
- Key role in a highly advanced and fast-growing startup company
- Impactful product promoting better understanding and treatment of cancer
- International team, from over 30 different nationalities
- Positive work environment with open communication and a collaborative mindset
- Hybrid working model possible
- Indefinite employment contract
- 30 vacation days
- Flexible working hours
- Annual health budget (Allianz bKV)
- EGYM Wellpass
- Relocation support