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

NVision Imaging Technologies; Laurel (MD); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Stock options

Relocation support

Annual health budget

EGYM Wellpass

Hybrid work model

30 vacation days

Job summary

NVision Quantum in Laurel, MD seeks an experienced Risk Management Engineer (Devices) to own risk analysis across in-house setups and our device portfolio. You will drive FMEA, safety documentation, and regulatory alignment with R&D, Systems Engineering, and Regulatory teams to ensure robust safety and quality across the lifecycle of our experimental equipment and products.

The role emphasizes translating risks into concrete safety controls, aligning with V&V strategies, and maintaining

Qualifications

• Experience leading risk analysis, FMEA, and safety documentation for complex devices.
• Familiarity with ISO 12100 and ISO 14971; V-Model product development lifecycle is a plus.
• Excellent facilitation and cross-functional collaboration skills across R&D, systems engineering, and regulatory teams.

Responsibilities

• Own risk analysis, FMEA, and technical safety documentation across projects.
• Coordinate cross-functional risk assessments with engineers, scientists, and HSE teams.
• Translate risks into safety controls and design specifications aligned with V&V plans.
• Ensure compliance with device safety standards and audit readiness.

Skills

Communication

English proficiency

Education

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

Job description

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.

• 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

• 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

Join us in making a difference!

Jessica Addo

Talent Acquisition Manager

Email: [e-mail]

Web: www.nvision-quantum.com