Senior Human Factors Engineer

Jobtailor; Salt Lake City (UT); On-site; USD 110,000 - 160,000; Full time

Job summary

Jobtailor in Utah seeks a Senior Human Factors Engineer to lead usability programs for medical devices. You will conduct contextual inquiry, usability testing, and risk analyses, translating insights into actionable design requirements and regulatory submissions.

The role collaborates with R&D, Regulatory, and Quality teams, with about 25% travel and strong emphasis on user-centered design and post-market surveillance.

Qualifications

• Bachelor's degree in a related field (Human Factors, Biomedical, Industrial Design, Cognitive Science, Psychology).
• At least 5 years of professional experience in human factors engineering.
• 5+ years in the medical device industry (Class II/III) experience.
• Familiarity with FDA guidance, IEC 62366, and ISO 14971.
• Strong written and verbal communication, analytical and problem-solving skills.

Responsibilities

• Lead and execute human factors engineering activities across the product lifecycle.
• Conduct contextual inquiry, ethnographic studies, usability testing, surveys, and interviews.
• Develop user profiles, task analyses, use scenarios, and use-related risk analyses.
• Translate findings into design recommendations and requirements.
• Collaborate with R&D, Marketing, Regulatory, Quality, and Clinical Affairs teams.
• Participate in design reviews and provide expert input on usability.
• Create human factors plans, reports, and regulatory documentation including IEC 62366 and FDA guidance.
• Mentor junior human factors engineers and promote user-centered design.
• Stay current with industry best practices, emerging technologies, and regulatory requirements.

Skills

Human Factors Engineering

Usability Testing

User-Centered Design

Contextual Inquiry

Ethnographic Studies

FDA Guidance

IEC 62366

ISO 14971

Post-Market Surveillance

Communication Skills

Education

Bachelor's degree in a related field

Job description

• Lead and execute human factors engineering activities throughout the product development lifecycle, from concept generation to post-market surveillance
• Conduct contextual inquiry, ethnographic studies, usability testing, surveys, and interviews to identify user needs, preferences, and pain points
• Develop and refine user profiles, task analyses, use scenarios, and use-related risk analyses
• Translate user research findings into actionable design recommendations and requirements
• Collaborate with R&D, Marketing, Regulatory, Quality, and Clinical Affairs teams
• Participate in design reviews and provide expert input on user interface, workflow, and overall usability
• Create human factors plans, reports, and regulatory documentation, including IEC 62366 and FDA guidance documentation
• Mentor junior human factors engineers and promote user-centered design
• Stay current with industry best practices, emerging technologies, and regulatory requirements

Requirements

• Bachelor's degree in Human Factors Engineering, Biomedical Engineering, Industrial Design, Cognitive Science, Psychology, or a related field
• Minimum of 5 years of professional experience in human factors engineering
• Minimum of 5 years of experience specifically in the medical device industry, such as Class II or Class III devices
• Strong understanding of human factors principles, usability engineering, and user-centered design methodologies
• Proficiency in usability testing, contextual inquiry, surveys, and interviews
• Working familiarity with FDA guidance, IEC 62366, and ISO 14971
• Excellent written and verbal communication skills
• Strong analytical and problem-solving skills
• Ability to work independently and collaboratively in a fast-paced environment
• Approximately 25% travel, about once per quarter

Core Competencies

Demonstrates expertise in human factors engineering, usability testing, and user-centered design methodologies within the medical device industry. Proficient in regulatory documentation and collaboration with cross-functional teams to enhance product usability and compliance.

Highest-signal resume keywords

• Human Factors Engineering
• Usability Testing
• FDA Guidance
• IEC 62366
• User-Centered Design

ATS Optimization Keywords

Hard Skills

• Contextual Inquiry
• Ethnographic Studies
• Surveys
• Interviews
• Task Analyses
• Use Scenarios
• Use-Related Risk Analyses
• Design Recommendations
• Regulatory Documentation
• Usability Engineering

Soft Skills

• Excellent Communication Skills
• Analytical Skills
• Problem-Solving Skills
• Collaboration
• Mentoring

Industry Keywords

• Medical Device Industry
• Class II Devices
• Class III Devices
• ISO 14971
• Post-Market Surveillance