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Human Factor Engineer-Application Re-engineering

Tephra Inc.
Milpitas, CA Full Time
POSTED ON 3/18/2025 CLOSED ON 4/7/2025

What are the responsibilities and job description for the Human Factor Engineer-Application Re-engineering position at Tephra Inc.?

Description :

Job Title Human Factors Engineer

Relevant Experience

in Yrs) 6 years

Technical / Functional Skills

  • Ability to lead usability engineering activities (i.e. establishing usability requirements; creating usability risk analyses, study protocols, and study reports) for a complex, software-controlled electro-mechanical medical device.
  • Ability to collaborate with and across various groups and levels of management within the organization, including other engineering groups, marketing, clinical applications, and regulatory.
  • Good understanding of FDA Quality System Regulation, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, and Medical Device Directives (MDD) requirements, IEC 62304 Medical Device Software - Software Lifecycle Processes, General Principles of Software Validation - FDA Guidance, and IEC 62366 Medical Devices - Application of Usability

Experience Required

  • Minimum 5 years of experience in design or evaluation of user interfaces, Usability engineering, or equivalents.
  • Experienced with all phases of the product development life cycle including feasibility, planning, requirements, design and development, V&V, and design transfer.

    • Roles & Responsibilities

  • Responsible for : usability specifications, task analyses, usability risk analyses, and UI evaluation plans for products in collaboration with SW / HW engineers, clinicians, and product managers.
  • Strategize, design and execute usability studies at various stages of product development from early prototypes through formative and summative evaluations.
  • Author usability study protocols and reports, moderate studies, and analyze study data.
  • Advise regulatory, Quality, and R&D teams regarding compliance with IEC 62366, FDA Human Factors Engineering Guidance, and HE75 guidance
  • Manage and drive company SOP's / policies / procedure for alignment with human factors engineering standards and guidance documents

    • Generic Managerial Skills

  • Must have strong organizational, analytical and problem-solving skills
  • Must have keen time management skills
  • Ability to work in a team proactively, flexibly in an environment

    • Education

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