Human Factors Engineer

5 days ago


Milpitas, California, United States TEPHRA Full time
Job Title

Human Factors Engineer - Application Re-engineering Specialist

Job Summary

We are seeking a highly skilled Human Factors Engineer to join our team at TEPHRA. As a Human Factors Engineer - Application Re-engineering Specialist, you will be responsible for leading usability engineering activities, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Lead usability engineering activities, including establishing usability requirements, creating usability risk analyses, study protocols, and study reports.
  • Collaborate with various groups and levels of management within the organization, including engineering groups, marketing, clinical applications, and regulatory.
  • Develop and maintain a good understanding of FDA Quality System Regulation, ISO Quality System requirements, ISO Risk Management requirements, and Medical Device Directives (MDD) requirements.
  • Manage and drive company SOPs/policies/procedures for alignment with human factors engineering standards and guidance documents.
Requirements
  • Minimum 5 years of experience in design or evaluation of user interfaces, usability engineering, or equivalents.
  • Experience with all phases of the product development life cycle, including feasibility, planning, requirements, design and development, V&V, and design transfer.
  • Strong organizational, analytical, and problem-solving skills.
  • Keen time management skills and ability to work in a team proactively and flexibly.
Education

B.S. degree in Human Factors Engineering, or Industrial Design.



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