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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