Human Factors Engineer

4 days ago


Milpitas, California, United States TEPHRA Full time
Job Title: Human Factors Engineer - Application Re-engineering

We are seeking a highly skilled Human Factors Engineer to join our team at TEPHRA. As a key member of our product development team, you will be responsible for ensuring that our medical devices are designed with the user in mind.

Key Responsibilities:
  • Lead usability engineering activities, including establishing usability requirements, creating usability risk analyses, study protocols, and study reports for complex software-controlled electro-mechanical medical devices.
  • 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.
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.
What We Offer:
  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.


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