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

NVision Quantum Technologies; Ulm; Hybrid; EUR 85,000 - 125,000; Full time

Benefits offered by this job

Stock options

Relocation support

Hybrid working model

30 vacation days

Annual health budget

Job summary

NVision Quantum Technologies is seeking an experienced Risk Management Engineer (Devices) to own risk analysis for our in-house setups and device portfolio. You will collaborate with R&D, Systems Engineering and Regulatory teams to ensure safety and quality compliance throughout the lifecycle of our experimental equipment and products.

You will lead FMEA processes, document Technical Safety Data, and align mitigations with V&V strategies, ISO 12100, and ATEX considerations, while facilitating

Qualifications

• BSc/MSc/PhD in Engineering, Physics, or related field.
• 4+ years in risk management, systems engineering, or quality/regulatory engineering.
• Experience owning FMEA and Technical Safety Documentation.

Responsibilities

• Own risk analysis and FMEA for devices and lab equipment.
• Lead cross-functional risk assessment sessions with R&D, Systems Engineering, and HSE.
• Maintain Device Risk Analysis documentation and Technical Safety Documentation.

Skills

Risk management

FMEA ownership

Systems engineering

Regulatory engineering

Communication in English

Education

B.Sc./M.Sc./Ph.D. in Engineering/Physics

Tools

ISO 12100 knowledge

ATEX/IECEx knowledge

V-Model lifecycle

V&V strategies

Job description

Your mission

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.

Your profile

• 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

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

• 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

Contact information

Jessica Addo

Talent Acquisition Manager

Email:[e-mail]

Web: www.nvision-quantum.com