Clayton Smith

Experience

1. Sr Human Factors Consultant

   Krayton Innovations

   Nov 2023 — Present · Houston, TX, US

   Consultant/Contractor and co-founder of a small, independent human factors (HF) consulting practice, specializing in HF applications for medical device and combination product development, as well as quality / manufacturing operations.Collaborate with client teams to develop human factors/usability plans and conduct related analyses (e.g, task analysis, known use problems analysis, use-related risk analysis, heuristic evaluations) aligned with regulatory expectations and industry best practices.Design and execute formative and summative (validation) usability studies for a wide range of medical products and user groups, providing comprehensive support from study design through analysis and reporting.Apply working knowledge of key human factors standards, guidances, and regulatory references including IEC 62366, FDA Design Controls and HF guidances, ISO 13485, ISO 14971, ANSI/AAMI HE75, and relevant AAMI HF-related TIRs.Advise clients on integrating human factors into product development and quality system processes, with emphasis on safe and effective use in real-world environments.

Education

• Texas A&M University

  Bachelor’s Degree

  2011 — 2015

• Texas A&M University

  Masters of Engineering (M.Eng)

Skills

• Matlab
• Medical Devices
• Aseptic Processing
• Lean Manufacturing
• Microsoft Office
• Engineering
• Young People
• 3d Printing
• Investigation
• Non-Conforming
• Solidworks
• R&D
• Biomedical Engineering
• Gmp
• Trackwise
• Technical Writing
• Catsweb
• Biomaterials
• Pharmaceutical Manufacturing
• Public Speaking
• Polymers
• Communication
• Environmental Monitoring
• Labview