Senior Human Factors Engineer

Jobtailor; Batesville (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a Human Factors Engineer to lead HF activities for medical devices and healthcare products. You will plan studies, assess use-related risks, and develop comprehensive HF documentation to support regulatory submissions.

The role requires collaboration across R&D, marketing, clinical, and engineering teams to drive user-centered design and continuous improvement across multiple product portfolios.

Qualifications

• Bachelor’s degree or equivalent in Human Factors Engineering, Human-Computer Interaction, Psychology, Biomedical Engineering, Industrial Engineering, or related area
• 3+ years of human factors/usability engineering experience in medical devices or regulated industry
• Experience applying human factors methods including user research, task analysis, use-related risk analysis, and usability testing
• Knowledge of IEC 62366-1, FDA Human Factors Guidance, ANSI/AAMI HE75, ISO 14971, and medical device design controls
• Experience authoring human factors documentation, protocols, and reports to support development controls and regulatory submissions
• Strong understanding of user-centered design principles, usability evaluation methods, and qualitative data analysis
• Ability to independently solve complex usability challenges, develop actionable recommendations, and collaborate across cross-functional teams
• Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is unavailable
• Preferred: Advanced degree or equivalent experience in a related field, experience conducting IRB-reviewed studies, FDA submissions, or human factors research within clinical or healthcare settings

Responsibilities

• Plan and complete human factors engineering activities, including project plans, timelines, and deliverables
• Conduct use-related risk assessments, identify potential use errors, and support risk mitigation activities
• Plan, complete, and detail formative and summative usability studies in compliance with applicable regulations and standards
• Develop and maintain human factors documentation, including user needs, task analyses, interface specifications, and study reports
• Communicate human factors progress, findings, and risks to project teams and key collaborators
• Lead and deliver human factors workstreams for complex programs or multiple concurrent projects with minimal supervision
• Collaborate with R&D, marketing, clinical, and engineering teams to evaluate concepts, improve usability, and drive user-centered design decisions
• Apply human factors, usability, and user experience guidelines to support continuous improvement and successful product development
• Support development of new products and sustaining engineering initiatives for hospital beds, mobile and overhead patient lift systems, and other product portfolios

Job description

• Plan and complete human factors engineering activities, including project plans, timelines, and deliverables


• Conduct use-related risk assessments, identify potential use errors, and support risk mitigation activities


• Plan, complete, and detail formative and summative usability studies in compliance with applicable regulations and standards


• Develop and maintain human factors documentation, including user needs, task analyses, interface specifications, and study reports


• Communicate human factors progress, findings, and risks to project teams and key collaborators


• Lead and deliver human factors workstreams for complex programs or multiple concurrent projects with minimal supervision


• Collaborate with R&D, marketing, clinical, and engineering teams to evaluate concepts, improve usability, and drive user-centered design decisions


• Apply human factors, usability, and user experience guidelines to support continuous improvement and successful product development


• Support development of new products and sustaining engineering initiatives for hospital beds, mobile and overhead patient lift systems, and other product portfolios

Requirements

• Bachelor’s degree or equivalent experience in Human Factors Engineering, Human-Computer Interaction, Psychology, Biomedical Engineering, Industrial Engineering, or a related area


• 3+ years of human factors/usability engineering experience in medical devices or another regulated industry


• Experience applying human factors methods, including user research, task analysis, use-related risk analysis, and usability testing


• Knowledge of IEC 62366-1, FDA Human Factors Guidance, ANSI/AAMI HE75, ISO 14971, and medical device design controls


• Experience authoring human factors documentation, protocols, and reports to support development controls and regulatory submissions


• Strong understanding of user-centered design principles, usability evaluation methods, and qualitative data analysis


• Ability to independently solve complex usability challenges, develop actionable recommendations, and collaborate across cross-functional teams


• Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is unavailable


• Preferred: Advanced degree or equivalent experience in a related field, experience conducting IRB-reviewed studies, FDA submissions, or human factors research within clinical or healthcare settings

Core Competencies

Demonstrates expertise in Human Factors Engineering and Usability Testing, with a strong focus on user-centered design principles and regulatory compliance in medical device development. Proficient in conducting risk assessments, usability studies, and authoring documentation to support product development and regulatory submissions.

Highest-signal resume keywords

• Human Factors Engineering


• Usability Testing


• Risk Assessment


• User-Centered Design


• Regulatory Compliance

Hard Skills

• User Research


• Task Analysis


• Usability Evaluation


• Qualitative Data Analysis


• Human Factors Documentation


• Usability Study Design


• IEC 62366-1


• FDA Human Factors Guidance


• ANSI/AAMI HE75


• ISO 14971

Soft Skills

• Collaboration


• Problem Solving


• Communication


• Leadership

Industry Keywords

• Medical Devices


• Regulated Industry


• Clinical Settings


• Healthcare


• IRB-Reviewed Studies