Human Factors Engineer
5 days ago
Human Factors Engineer - Application Re-engineering Specialist
Job SummaryWe 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.
- 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.
B.S. degree in Human Factors Engineering, or Industrial Design.
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