Risk Engineer – Medical Device

Quantum Surgical

. Develop and maintain product risk management files .

Posted 11/7/2026full-timeMontpellier • FranceSeniorLead💰 €45,000 - €55,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in risk management within the medical device industry, including conducting FMEAs, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. Possesses strong analytical skills and technical documentation abilities, with a focus on product safety and usability.

Highest-signal resume keywords

Risk ManagementFMEA LeadershipISO 13485 KnowledgeRegulatory ComplianceAnalytical Problem-Solving

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk Management ActivitiesProduct Risk AnalysisQuality Management SystemsDesign ControlsBenefit-Risk AnalysisTechnical DocumentationUsability TestingClinical Performance UnderstandingPost-Market SurveillanceCorrective and Preventive Action Plans

Soft Skills

Excellent CommunicationCustomer-Focused ApproachCollaboration with Diverse TeamsStrong Analytical SkillsProblem-Solving Skills

Certifications & Qualifications

Risk Management Training

Industry Keywords

Medical DevicePharmaceutical IndustryISO 14971IEC 62366IEC 62304FDA 21 CFR 820Clinical EnvironmentOperating-Room ConstraintsBiocompatibilityClinical Trial Processes

About the role

Key responsibilities & impact

Develop and maintain product risk management files
Perform risk management activities with cross-functional teams to ensure product safety and compliance
Understand clinical performance, product functionality, and the operating-room environment
Participate in and organize risk management activities throughout the product lifecycle, through post-market surveillance
Advise and guide engineering teams involved in risk management
Conduct product and process risk analyses, particularly FMEAs
Identify residual risks and perform the associated benefit-risk analysis
Create and update risk management documentation
Collaborate with subject-matter experts responsible for medical device usability
Ensure compliance with quality procedures, regulatory requirements, and applicable industry standards
Participate in the preparation of CE-marking and 510(k) regulatory dossiers
Participate in nonconformity management and change control
Participate in complaint handling and assess associated risks
Participate in the development of corrective and preventive action plans
Collaborate with Systems, Software, Robotics, Mechanical Engineering, Integration, Verification and Validation (IVV), Quality, Regulatory Affairs, Clinical, and Project Management teams

Requirements

What you’ll need

Engineering degree or Master’s degree with a specialization in Biomedical, Scientific, Mechanical Engineering, or an equivalent field
10 years of experience in risk management within the medical device or pharmaceutical industry
Knowledge of quality management systems, design controls, and risk management requirements
Knowledge of ISO 13485, ISO 14971, IEC 62366, IEC 62304, FDA 21 CFR 820, and FDA guidance
Ability to lead usability, design, and process FMEAs
Ability to work with people from diverse functions and backgrounds
Technical expertise in one or more engineering disciplines
Strong analytical and problem-solving skills
Pragmatic, customer-focused approach
Excellent communication and technical documentation skills
Full professional proficiency in English
Risk management training from a recognized institution is desirable
Experience with products incorporating software and electromechanical components is desirable
Knowledge of the clinical environment and operating-room constraints is desirable
Knowledge and skills in biocompatibility, cleaning, and sterilization are desirable
General knowledge of clinical trial processes and requirements is desirable
Knowledge and skills in medical device usability are desirable

Benefits

Comp & perks

Base salary plus variable compensation
Swile meal vouchers
Hybrid working policy: up to 2 days of remote work per week
Multicultural team and creative work environment
Stimulating technical challenges