Human Factors Engineer

: Human Factors Engineer -R&D

ESSENTIAL DUTIES

• Supports the strategy, planning, and execution of human factors engineering activities for various product development projects.
• Leads HFE work for projects with limited user interface changes with guidance from senior engineers.
• Conduct user-centered research including interviews, contextual inquiries, task analyses, and anthropomorphic evaluations for development of user and environment profiles, use specification, use scenarios, and usability/user interface requirements.
• Supports usability testing and execution of human factors formative and assumptive evaluations.
• Ensures that product development projects are following HFE process compliant with all Company policies and procedures as well as existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance.
• Analyzes field data and reviews literature and publications to identify existing usability issues with on-market products.
• Works with cross-functional teams to create and maintain use-related risk analyses and user interface requirements.
• Contributes to prototype design builds for usability testing, including graphical user-interface, hardware, or disposable components.
• Supports the development of internal tools for human factors data capture, analysis, and testing.
• Reinforces customer empathy and human-centered design approach across the organization.
• Keeps abreast of regulations and best practices for medical device human factors engineering (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices).

Skills

• Requires knowledge of product design and development process, preferably for medical devices.
• Working knowledge of human factors, design controls, and risk management regulations, standards, and guidances for medical devices.
• Strong interactive skills in cross-functional collaboration and influence, acceptance of guidance, technical leadership, proactive communication, and accountability.
• Ability to influence without authority to drive user-centered design thinking and solutions.
• Strong technical writing skills for writing protocols and reports for regulatory submissions.
• Demonstrated critical-thinking and problem-solving skills.
• Strong interpersonal skills and ability to properly engage users and customers while not compromising research and data collection.
• Highly organized and able to work efficiently across multiple projects in parallel.
• Demonstrated ability to communicate and present data and results effectively to broad audiences.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

Experience

• Minimum 2 years experience.
• Experience with Human Factors/Usability in medical devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance, preferred.
• Experience with risk management activities applied by Human Factors to medical devices (i.e. URA, UFMEA, AFMEA, UEA techniques), preferred.