Risk Management Engineer (Devices) (m/f/d)

Entangled Future; Ulm; Hybrid; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Relocation support

Stock options

Job summary

Entangled Future in Ulm is seeking an experienced Risk Management Engineer (Devices) to own risk analysis across in-house setups and our device portfolio. You will serve as the central contact for risk information across R&D, Systems Engineering, and Regulatory teams to ensure safety and quality throughout development.

You will lead FMEA and develop Device Risk Analysis and Technical Safety Documentation, guiding risk mitigations from concept to lifecycle.

Qualifications

• Bachelor's, Master's, or PhD in engineering, physics, or related field.
• 4+ years' experience in risk management, systems engineering, or quality/regulatory engineering.
• Proven ownership of FMEA and Technical Safety Documentation.
• Experience with ISO 12100 and safety standards in devices.
• Strong English communication; German language skills are a plus.
• Onsite or hybrid work arrangement in Ulm (2–3 days/week).

Responsibilities

• Drive and manage risk analysis and FMEA for complex setups and equipment.
• Moderate cross-functional risk assessment sessions with experts and HSE.
• Build and maintain Device Risk Analysis documentation and Technical Safety Documentation.
• Translate risks into safety controls and design specifications for internal setups and product development.
• Align mitigations with testing protocols and Verification & Validation strategies.

Skills

Risk management

FMEA ownership

Safety documentation

English communication

Education

BSc/MSc/PhD in Engineering/Physics

Tools

ISO 12100

ISO 14971

ATEX/IECEx

V-Model

Job description

• The posting mentions relocation support.

About the role

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.

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.

Why us?

• 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

What they're looking for

• 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.
• 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, ideally in the field of medical devices, laboratory equipment or aerospace/aerotech.
• Demonstrated experience owning the 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, with the ability to facilitate technical risk alignment across multi disciplinary 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 our Ulm office

Interested in this role?

NVision Imaging Technologies, a spin-off from Ulm University's quantum institutes, applies quantum spin control of organic molecules to two platforms: POLARIS, a hyperpolarization system for metabolic MRI, and PIQC, a quantum computing platform built on molecular qubits with photonic interfaces.