DHF Analysist - Risk Management and Usability Engineer

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

Strong 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.

Roles and Responsibilities
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.