WHAT DOES A HUMAN FACTORS ENGINEER DO?

Published: July 17, 2025 - The Human Factors Engineer supports the development of next-generation cardiac ablation products by conducting user research, defining requirements, and developing design concepts and prototypes. This role leads usability evaluations, task and error analyses, and ensures the integration of human factors principles across cross-functional teams throughout the product development lifecycle. The engineer manages project deliverables, interfaces with customers professionally, and contributes to creating safe and effective user experiences.

A Review of Professional Skills and Functions for Human Factors Engineer

1. Human Factors Engineer Duties

  • Task Analysis: Develop Use Specifications and Task Analysis to support the development of Customer, System, and Product Requirements
  • Usability Risks: Assess and document use errors and advise the team on usability risks and mitigations
  • Study Execution: Develop, plan, execute, analyze, and document experimental studies, and draw relevant conclusions
  • Protocol Development: Develop Formative and Summative Usability Validation Protocols and Reports
  • Usability Testing: Conduct usability studies and design iteration assessments of products, both internally and with external key opinion leaders
  • Design Improvement: Apply psychological and design principles to user interfaces to provide recommendations for improvements to usability or mitigate user risk
  • User Research: Plan and conduct worldwide customer, competitive, and software industry research to identify and prioritize usability improvement possibilities and solutions
  • Usability Oversight: Provide human factors and usability input and oversight on programs
  • Task Prioritization: Prioritize tasks by distinguishing urgent from important tasks and assessing cost/benefit trade-offs
  • Clinical Knowledge: Develop understanding of the scientific, technical, medical, and clinical aspects of Abbott neuromodulation devices and features and the disease states they aim to treat
  • HF Evaluation: Support human factors evaluation of new or enhanced products
  • Needs Analysis: Identify potential product enhancements and new product ideas by applying an analytical approach to understanding user needs
  • Regulatory Trends: Maintain a detailed understanding of the developing human factors environment (e.g., evaluation methods, evolving regulatory landscapes, etc.)
  • Regulation Compliance: Maintain a detailed understanding of Abbott, FDA 21 CFR Part 820, and ISO regulations

2. Human Factors Engineer Details

  • Program Management: Be responsible for program requirements, deadlines, interactions with outside teams, direct leadership/customer interactions, and direction of the small, geographically-dispersed team
  • System Design: Apply human factors principles, methodologies, and technologies to the design of human-machine systems and products
  • Digital Integration: Lead Digital Integration activities, developing Virtual and Augmented reality platforms and use in virtual maintainer/operator simulations
  • System Evaluation: Performing evaluations in such areas as anthropometry/biomechanics, systems architecture, test/operator/maintainer interface usability, and human-computer interaction
  • Technical Coordination: Coordinate technical requirements across engineering fields
  • Design Review: Participate in hardware and Software design and reviews
  • Architecture Assessment: Evaluate and assess system architecture, and evaluate human capabilities and impacts of the system environment
  • Protocol Execution: Writes and executes moderately complex system-related (i.e., hardware, software, labeling and/or assays) protocols, analyzes data, and writes data summaries by governing procedures
  • Error Analysis: Facilitate the use of error analysis and conduct user research
  • Usability Testing: Develop and execute formative and summative usability protocols
  • Data Evaluation: Applies quantitative methods, analyzes data, evaluates results, forms conclusions and provides/implements improvements

3. Human Factors Engineer Responsibilities

  • Usability Implementation: Work on the implementation of human factors/usability engineering and ensure compliance with the given regulations for medical device(s)
  • Task Analysis: Plan, perform and document Human Factors/Usability Engineering efforts, including defining user profiles, task analysis, formative and summative evaluations
  • Audit Preparation: Ensure that the usability engineering file is complete and ready for audits
  • Quality Collaboration: Work closely with the Regulatory and Quality Team to ensure a strong QMS and contribute to risk management
  • Product Development: Collaborate closely with the Design and Product Team in developing easy-to-use products that delight users
  • User Research: Identify user needs, problems and requirements from early on design exploration to optimization
  • Process Improvement: Contribute to improving processes around human factors/usability engineering and human-centered design
  • Insight Communication: Communicate user insights and usability engineering to the company
  • File Redesign: Support the current redesign of the usability engineering file
  • Engineering Leadership: Lead usability engineering activities for a software medical device according to IEC 62366, FDA and MHRA (creating documentation and following standard guidelines)

4. Human Factors Engineer Job Summary

  • Human Factors Leadership: Lead Human Factors activities
  • Project Representation: Represents HFE function on multiple projects and provides schedule and status to the team
  • Usability Planning: Plans, coordinates, and moderates usability studies at various stages of product development from early prototype testing through formal human factors validation/summative testing
  • Design Review: Conducts or participates in technical design reviews of requirements, specifications, designs, etc
  • Feature Analysis: Collaborates with the team to analyze new features and product proposals, articulate what HFE activities are, develop HFE plans and timelines, and identify and communicate potential risks
  • Compliance Assurance: Ensures compliance with internal Human Factors procedure and latest Human Factors standards and guidance documents
  • Regulatory Support: Prepares and reviews documents for submission to regulatory agencies and notified bodies
  • Technical Guidance: Answers questions and provides rationales
  • Safety Advisory: Advise the team on actions and approaches leading to the safe and effective production of healthcare products
  • Lifecycle Integration: Conduct of Human Factors Integration through the development lifecycle, providing progressive assurance to the customer as per Def Stan 00-251
  • Operator Analysis: Analysis and assessment of the role of the operator within the weapon system, considering weapon system planning, command and control
  • Ergonomic Assessment: Analysis of physical ergonomics and integration into workspaces
  • Requirements Definition: Define HF requirements and development and maintenance of lower-level detailed specifications
  • User Testing: Conduct User Experiments and Trials supporting system concepting, development and verification

5. Human Factors Engineer Accountabilities

  • Seating Development: Help with seating development, measuring, controlling development, to production
  • Reference Establishment: Help establish various seating reference points
  • Design Assistance: Assists Industrial Designers through critical thinking and problem-solving of human factors
  • Engineering Collaboration: Work with and influence engineers and suppliers
  • Project Leadership: Lead HFE activities for the project in partnership with functional engineering groups, quality, regulatory, marketing, clinical, and R&D to ensure that those products are safe and meet the needs of the customers
  • User Research: Lead HFE activities and provide input based on user research and usability evaluations to enable the design of user interfaces
  • Interface Recommendation: Provide user interface design recommendations and collaborate with cross-functional functionally on user interface design solutions
  • Training Support: Collaborate and provide input into IFU content and training materials
  • Communication Delivery: Deliver verbal, written, and visual communications, with an emphasis on problem framing, visual storytelling, and clear user interface design issues or recommendations to internal and external key stakeholders

6. Human Factors Engineer Functions

  • Human Factors Support: Support Human Factors (HF) and usability activities that inform design decisions to create products that are efficient, effective and safe
  • Usability Leadership: Lead and/or conduct usability activities such as planning, protocol/discussion guide development, data collection, analysis, and documentation for formative and summative evaluations
  • Risk Analysis: Author and update usability risk analyses
  • Documentation Preparation: Prepare documentation to support development activities, design controls, DHF, UEF, including protocols, task analysis, risk assessment, HF reports/plans and regulatory submissions
  • Data Analysis: Analyze quantitative and qualitative data from usability studies that inform alternative design solutions
  • Cross-functional Collaboration: Collaborate cross-functionally with engineering, marketing, design assurance and regulatory to ensure user needs are aligned with research and test findings
  • Regulatory Support: Support and provide Human Factors Engineering (HFE) expertise for usability testing and regulatory submissions by HF best practices
  • Process Improvement: Analyze existing HF practices and documentation, create a gap analysis, and find opportunities for improvement
  • Template Development: Develop and manage HF documentation templates for internal use
  • Partnership Management: Manage external partnerships during the execution of user research/usability testing activities

7. Human Factors Engineer Job Description

  • Usability Leadership: Lead planning and execution of formative and summative usability studies to evaluate current and future Dexcom products
  • Data Analysis: Analyze data and compile study findings for multidisciplinary teams of designers, engineers, and product managers across the company
  • Regulatory Documentation: Author HFE documentation for creating Usability Engineering File for regulatory submissions according to the requirements of medical device regulators around the world (FDA HFE Guideline, IEC 62366, ANSI / AAMI HE75)
  • Vendor Management: Establish relationships with third-party vendors for usability study recruitment and coordination
  • Formative Evaluation: Conduct Task Analyses, Usability Audits, Cognitive Walkthroughs, and other formative design and evaluation methods
  • User Advocacy: Advocate for user needs and drive design recommendations based on usability standards and best practices
  • Project Management: Manage human factors activities across various projects and provide schedules and status to management
  • Requirements Review: Review and provide feedback on product requirements and evaluate risks related to product use (risk analysis)
  • Team Collaboration: Participate in cross-functional core team meetings to ensure human factors requirements are met

8. Human Factors Engineer Overview

  • Human Factors Leadership: Leading human factors elements of work on multidisciplinary engineering projects
  • Report Writing: Writing and providing analysis reports on work you've conducted
  • Team Development: Guiding and nurturing early career professionals within the team, as well as supervising their work
  • Project Management: Managing specific projects, initiating and supporting bid activities
  • Team Promotion: Promoting the human factors team and capabilities
  • Strategy Planning: Plan and implement human factors engineering strategy, including implementation practices and processes
  • Technical Analysis: Develop and apply analysis techniques for hardware to meet human factors requirements
  • Documentation Development: Generate Axiom procedures and documentation for human factors integration with the teams
  • Cross-Functional Collaboration: Collaborate with all engineering systems and subsystem teams to implement human factors into designs at hardware maturity
  • Design Evaluation: Support design reviews, evaluation and test activities
  • Presentation Preparation: Prepare technical documentation and presentations for peers, management, and external customers and partners

9. Human Factors Engineer Details and Accountabilities

  • Human Factors Application: Apply Human Factors Engineering (HFE) techniques and principles at all phases of product/technology development
  • Study Development: Develop user study criteria and detailed methodology for projects that focus on product comfort and span from formative to evaluative and qualitative to quantitative
  • User Research: Conduct user-centered research and evaluation on a diverse user population utilizing experimental data and scientific publications
  • Data Analysis: Conduct statistical and qualitative analyses of data and provide clear and concise feedback to teams promptly
  • Cross-Functional Collaboration: Collaborate cross-functionally with design, engineering, and product development groups
  • Standards Knowledge: Maintain an active working knowledge of worldwide human factors publications and standards
  • Ergonomic Development: Develop, validate, organize and maintain vehicle occupant package, ergonomic criteria, and processes
  • Solution Implementation: Work with engineering, styling and program management to implement optimum package ergonomic solutions for production vehicles
  • Design Assessment: Perform digital and physical assessments of the criteria against styling and engineering proposals
  • Focus Studies: Develop and run focus studies to establish ergonomic compliance

10. Human Factors Engineer Tasks

  • User Research: Support the design of next-generation cardiac ablation products, shaping the experience of its users
  • Project Coordination: Responsible for coordinating all activities necessary to complete Human Factors engineering projects
  • Needs Identification: Conduct ethnographic user research to identify user needs
  • Requirements Translation: Translate user needs into requirements and product design concepts
  • Prototype Development: Develop prototypes to explore and validate product design concepts
  • Error Analysis: Perform workflow, task and use error analyses
  • Usability Testing: Conduct Formative Usability and Summative Validation Testing
  • Team Collaboration: Participate in development program teams to ensure human factors principles are considered and implemented
  • Deliverable Management: Create and communicate project deliverables and manage time to meet project deadlines
  • Interface Design: Develop user interface design, user error analysis, usability, and validation testing
  • Technical Leadership: Work with cross-functional teams and provide technical leadership
  • Customer Interaction: Interface with customers in a highly professional manner