- 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 Quality System) requirements, ISO 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
- 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.
- Responsible for
- 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
- 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
- B.S. degree in Human Factors Engineering, or Industrial Design
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Human Factor Engineer-Application Re-engineering - Milpitas, United States - TEPHRA
Description
:Job Title Human Factors Engineer
Relevant Experience
(in Yrs) 6+ years
Technical/Functional Skills
usability specifications, task analyses, usability risk analyses, and UI evaluation plans for products in collaboration with SW/HW engineers, clinicians, and product managers.
