Job Title: Risk Management & Usability Engineer Job Summary Responsible for planning, executing, and maintaining Risk Management and Usability Engineering activities throughout the product lifecycle of Medical Devices and Software as a Medical Device (SaMD). The role ensures compliance with applicable regulatory standards and supports product safety, effectiveness, and user-centered design.

Key Responsibilities
Risk Management
· Lead and facilitate Risk Management activities in accordance with ISO 14971.
· Develop and maintain Risk Management Plans, Risk Analyses, Hazard Analyses, Risk Assessment Reports, and Risk Management Files.
· Conduct Product, System, Software, and Use-related Risk Assessments.
· Perform risk evaluations and define risk control measures.
· Ensure traceability between hazards, hazardous situations, harms, risk controls, and verification activities.
· Support post-market risk review and complaint trending activities. FMEA Activities
· Conduct and facilitate: o Design FMEA (DFMEA) o Usability FMEA (UFMEA) o Use FMEA (URFMEA) o Software FMEA (as applicable)
· Coordinate cross-functional discussion and meeting to identify failure modes and mitigations.
· Analyze Severity, Occurrence, and Detection ratings.
· Drive implementation and verification of risk control actions.
· Maintain FMEA documentation throughout product development and sustaining activities. Usability Engineering
· Execute usability engineering activities in accordance with IEC 62366-1 and FDA Human Factors guidance.
· Develop Use Specifications and User Profiles.
· Identify Use-related Hazards and Hazardous Use Scenarios.
· Perform Task Analysis and Use Error Analysis.
· Create and maintain Usability Engineering Files.
· Plan and support formative and summative usability evaluations.
· Participate in human factors validation testing and reporting. Regulatory & Compliance
· Ensure compliance with: o ISO 14971 o IEC 62366-1 o IEC 60601-1 (where applicable) o IEC 62304 (for software-based products)



o FDA Human Factors Guidance o MDR/EU Regulations and applicable quality procedures
· Support design reviews, audits, and regulatory submissions. Cross-Functional Collaboration
· Work closely with R&D;, Systems Engineering, Software, Clinical, Quality, Regulatory Affairs, and Product Management teams.
· Participate in design control and change management activities.
· Support CAPA, complaint investigations, and field actions related to risk and usability. Required Qualifications
· Bachelor's or Master's degree in: o Biomedical Engineering o Electronics Engineering o Mechanical Engineering o Software Engineering o Human Factors Engineering o Related discipline Required Experience
· 5-7 years of experience in Medical Device Product Development.
· Hands-on experience in Risk Management and FMEA execution.
· Experience developing and maintaining Risk Management Files.
· Experience conducting usability engineering and human factors activities.
· Exposure to regulatory audits and design control processes. Required Skills Technical Skills
· ISO 14971 Risk Management
· DFMEA / PFMEA / UFMEA
· Hazard Analysis
· Risk-Benefit Analysis
· Fault Tree Analysis (FTA)
· IEC 62366 Usability Engineering
· Human Factors Engineering
· Design Controls
· Traceability Management
· Medical Device Development Lifecycle Soft Skills
· Solid facilitation and stakeholder management skills
· Excellent analytical and problem-solving abilities
· Effective communication and technical writing skills
· Ability to work in global cross-functional teams Preferred Qualifications
· Experience with Class II/IIb/III Medical Devices.
· Experience with Software as a Medical Device (SaMD).
· Knowledge of cybersecurity risk assessments.
· Certified Human Factors or Risk Management training.
· Experience supporting FDA, MDR, and notified body audits. Keywords: ISO 14971, IEC 62366, DFMEA, PFMEA, UFMEA, Risk Management File, Human Factors, Usability Engineering, Hazard Analysis, Medical Devices, SaMD, Design Controls, IEC 62304, Regulatory Compliance.

📌 DHF Analysist (Bengaluru)
🏢 Cyient
📍 Bengaluru