Job Title Human Factors Engineer
(in Yrs) 6+ years
• 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
• 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
• B.S. degree in Human Factors Engineering, or Industrial Design