Human Factors Engineer

Real Staffing; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Specialist Staffing Group is seeking a Human Factors Engineer for medical devices to lead HF activities across the product lifecycle, ensuring user-centered design and regulatory compliance. Responsibilities include evaluating interfaces, contributing to risk assessments, and guiding design decisions with data-driven insights.

You will collaborate with engineering, clinical, quality, regulatory, and marketing teams to integrate HF requirements and support product development from concept to

Qualifications

• Bachelor's degree in Engineering, Human Factors Engineering, Biomedical Engineering, Industrial Design, or a related technical field.
• Minimum of 2 years of Human Factors, Usability Engineering, or UX experience.
• Experience conducting usability studies, task analyses, risk assessments, and UI evaluations.
• Experience designing, testing, and validating software and/or hardware UIs.

Responsibilities

• Lead Human Factors activities for new product development, ensuring user-centered design throughout.
• Evaluate prototype UIs to optimize usability, safety, and user experience.
• Provide recommendations for product and process improvements based on HF analyses and studies.
• Develop project plans, timelines, and budgets for HF initiatives.
• Serve as SME on HF standards, regulatory guidance, and best practices across the product lifecycle.

Skills

Human Factors Engineering

Usability Testing

Risk Analysis

Cross-functional teamwork

Education

Bachelor's degree in Engineering/Related Field

Tools

SolidWorks/Creo CAD

Design Control

Job description

Human Factors Engineer (Medical Devices)
Position Summary

The Human Factors Engineer is responsible for the design, development, testing, and validation of user interfaces for medical devices throughout the product lifecycle, including concept development, design, verification, validation, commercialization, and post-market support. This role ensures products are intuitive, safe, effective, and compliant with applicable regulatory and industry standards.

Key Responsibilities

• Lead Human Factors Engineering activities for new product development programs, ensuring user-centered design principles are incorporated throughout the product development process.
• Evaluate and assess prototype user interfaces to optimize usability, safety, and overall user experience.
• Provide recommendations for product and process improvements based on Human Factors analyses, usability studies, and user feedback.
• Develop project plans, timelines, and budget estimates for assigned Human Factors initiatives.
• Serve as a subject matter expert on Human Factors standards, regulatory guidance, and best practices, supporting cross-functional teams from concept through product retirement.
• Collaborate with engineering, clinical, marketing, quality, regulatory, and product management teams to ensure Human Factors requirements are properly integrated into product development.
• Lead and execute Human Factors activities, including:

Task Analyses
Perceptual, Cognitive, and Action (PCA) Analyses
Use-Related Risk Assessments (URRA)
Use Failure Mode and Effects Analyses (uFMEA)
Formative Studies
Summative (Validation) Studies

• Prepare and maintain Human Factors documentation in compliance with Design Control procedures and applicable regulatory requirements.
• Drive product enhancements, modifications, and design decisions based on data, usability findings, and risk assessments.
• Develop test protocols and reports for simulated-use evaluations, including study objectives, methodologies, and data analysis plans.
• Facilitate the planning, execution, and review of Human Factors activities while ensuring required inputs, dependencies, and deliverables are achieved on schedule.
• Provide regular updates on project status, risks, and progress to stakeholders and leadership.
• Support marketing and product management teams by providing technical expertise for product training materials and marketing initiatives.
• Mentor and guide junior Human Factors team members and coordinate project activities as needed.
• Travel domestically and internationally as required to support customer visits, evaluations, conferences, and industry events.

Required Qualifications

• Bachelor's degree in Engineering, Human Factors Engineering, Biomedical Engineering, Industrial Design, or a related technical field.
• Minimum of 2 years of Human Factors, Usability Engineering, or User Experience (UX) experience.
• Experience conducting usability studies, task analyses, risk assessments, and user interface evaluations.
• Experience designing, testing, and validating software and/or hardware user interfaces.
• Strong understanding of human information processing, perception, cognition, ergonomics, and user-centered design principles.
• Ability to work effectively within cross-functional product development teams.

Preferred Qualifications

• Experience in the medical device industry or another highly regulated environment.
• Knowledge of FDA Human Factors guidance and ISO standards related to medical device usability and risk management.
• Experience using 3D CAD software such as SolidWorks, Creo (Pro/ENGINEER), or similar design tools.
• Experience developing interactive wireframes, mockups, and graphical user interface prototypes.
• Knowledge of usability engineering methodologies, heuristic evaluations, and risk-based design processes.

Key Competencies

• Human Factors Engineering
• Usability Testing & Validation
• Medical Device Development
• Risk Analysis & Mitigation

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.