Open role
Human Factors Specialist
Addison Group is partnering with a global healthcare manufacturing company to identify a Human Factors Specialist to support usability and human factors initiatives. The role involves planning, executing, and documenting usability studies to support product development and regulatory compliance.
Responsibilities
- Provide execution support for human factors usability studies under established guidance
- Assist with formative and summative usability studies across multiple programs
- Coordinate study logistics including scheduling, preparation, and execution
- Participate on-site during usability testing sessions
- Serve as a moderator or observer during usability studies
- Capture detailed observations related to user behavior, errors, and use challenges
- Assist with qualitative and quantitative data analysis
- Contribute to usability and human factors documentation and reports
- Support review of labeling feedback and design recommendations
- Draft and update usability study protocols with direction from senior team members
- Ensure documentation aligns with applicable regulatory guidance and internal procedures
Skills
- Bachelor's Degree required
- Between 1-3 years of experience supporting human factors or usability studies
- Strong documentation, organizational, and analytical skills
- Proficiency with Microsoft Office applications
- Ability to be on-site during business hours (8:00 a.m. – 6:00 p.m.) for usability study sessions
- Medical Device experience preferred
- Exposure to FDA Human Factors Guidance, IEC 62366-1, ISO 14971, or ISO 13485 preferred
Benefits
- This position is eligible for medical, dental, vision, and 401(k).
- Hybrid work schedule
- Contract position for 6-8 months with hybrid flexibility
- Opportunity to gain experience supporting regulated product development
- Hands-on exposure to usability testing and human factors processes
- Collaboration with cross-functional teams including QA/RA and engineering
- Professional development within human factors and usability engineering
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