Human Factors Engineer

JOB SUMMARY

The Human Factors Engineer will conduct human factors research, analysis, and evaluation using standard human factors engineering theories, principles, and data to drive user-centered product design and development. Assignments include applying HFE to system user interface definition, design, and evaluation over the product life cycle. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, leadership opportunities, and company practices and policies.

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 summative 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).

OTHER DUTIES AND RESPONSIBILITIES

• Work assignments may require additional development and a maturing or broadening of in-depth engineering skill(s).
• Collaborate with other functional groups, technical disciplines, and levels of management including other engineering disciplines, Product Managers, UX Designers, Product Technology Leads, Marketing, Regulatory, Project Managers, and Product Support and Training.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Usability/Human Factors Engineering, Biomedical Engineering, Systems Engineering or related research-based degree, preferred.

Experience

• Minimum 3 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.

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 guidance's 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.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires domestic and international travel based on business needs.