Job Title Human Factors EngineerRelevant Experience (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