Workstream: DHF/Risk Remediation

Role: Risk Engineer Design Controls Remediation Role Summary The Risk Engineer supports risk management activities across the product lifecycle, from concept and development through verification, validation, launch and post-market monitoring. This role partners with Systems Engineering, Design Engineering, Software, Quality, Regulatory, Clinical, Manufacturing, Service and V&V; teams to identify hazards, evaluate risks, define risk controls and ensure appropriate objective evidence is generated to demonstrate risk acceptability.

The Risk

Engineer is central to maintaining product safety, regulatory compliance and design control traceability in accordance with applicable regulations, standards and quality management system requirements.

Responsibilities Lead or support product risk management activities in accordance with ISO 14971 and related regulatory expectations.

Develop, maintain and update risk management documentation, including hazard analyses, risk assessments, risk control plans, risk management reports and risk traceability matrices.

Facilitate cross-functional risk analysis sessions with engineering, clinical, quality, regulatory, usability, service and manufacturing stakeholders.

Identify product hazards, hazardous situations, foreseeable misuse, sequences of events, harms, severity, probability and overall risk acceptability.

Partner with engineering teams to define risk controls, including inherent safety by design, protective measures, alarms, labeling, usability mitigations, software controls and process controls.

Ensure risk controls are translated into clear requirements and traced to verification and validation evidence.

Collaborate with V&V; teams so that test protocols adequately verify risk controls and support residual risk acceptability.





Support usability engineering and use-related risk analysis, including evaluation of user interface hazards and use-error mitigations.

Support security risk management and cybersecurity-related risk analysis for connected and software-driven products, including threat modeling, security risk assessment and traceability of security controls into the risk management file.

Review design changes, field issues, complaints, nonconformances, corrective and preventive actions (CAPAs) and post-market data for potential risk impact.

Support risk-based decision-making during design reviews, change control, issue resolution and product release readiness.

Prepare risk management content for regulatory submissions, audits and design documentation.

Maintain alignment between risk management files, requirements, design outputs, labeling, verification evidence and post-market surveillance data.

Support continuous improvement of risk management processes, templates, tools and best practices.

Qualifications Bachelor's degree in Engineering, Biomedical Engineering, Systems Engineering, Mechanical Engineering, Electrical Engineering, Software Engineering or a related technical discipline.

Experience in medical device, diagnostics, life sciences, healthcare technology, aerospace, automotive or another regulated industry.

Working knowledge of risk management principles, design controls, requirements management,



verification and validation, and product lifecycle processes.

Ability to facilitate technical discussions and drive alignment across cross-functional teams.

Strong analytical, problem-solving and documentation skills.

Ability to evaluate complex technical information and translate it into clear risk-based conclusions.

Strong attention to detail and commitment to product safety and quality.

Excellent written and verbal communication skills.

Preferred Qualifications Experience applying ISO 14971 in a medical device development environment.

Familiarity with the FDA Quality Management System Regulation (QMSR), EU MDR, ISO 13485, IEC 62304, IEC 62366, IEC 60601 or related standards.

Familiarity with risk management for artificial intelligence, machine learning and Software as a Medical Device (SaMD), including ISO/TS 24971-2, AAMI TIR34971, IEC 82304-1 and ISO/TS 82304-2.

Working knowledge of AAMI technical information reports supporting risk management, including AAMI TIR57 and ANSI/AAMI SW96 for cybersecurity and AAMI TIR59 for usability and human factors.

Experience with hazard analysis, failure mode and effects analysis (FMEA), fault tree analysis, use-related risk analysis or system safety analysis.

Experience with requirements and traceability tools such as Jama, Polarion, DOORS or Azure DevOps.

Experience with software-driven, electromechanical, imaging, diagnostic or connected medical devices.

Familiarity with post-market surveillance, complaint analysis, CAPA, change control and risk file updates.

Certification or training in risk management, quality engineering, systems engineering or reliability engineering.

Reporting Structure Reports to: Workstream Lead DHF/Risk Remediation

📌 Risk Engineer — Design Controls Remediation (México)
🏢 QvalFocus
📍 México