- 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