Staff Human Factors Engineer

Job Overview

The Staff Human Factors Engineer will be responsible for taking a role in Usability and Human Factors engineering efforts at XXX. This role will apply human performance principles, methodologies, and technologies to the design of human/machine systems and products. The Staff Human Factors Engineer will develop and implement research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of products development and processes, and designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, use related risk identification and formal usability validation with intended users. They also identify and analyze technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.

Duties/Responsibilities

• Collaborate closely with multi-functional teammates in Clinical Engineering, R&D, Marketing, Quality, and Regulatory to collaborate on product features and functionality.
• Subject matter expert and technical leader in human factors engineering responsible for lifecycle application of human factors design process, principles, analysis, and usability testing methods.
• Develop and implement research methodologies including both qualitative and quantitative analysis plans to test and evaluate new concepts and developmental prototypes used in all phases of product development.
• Design and execute tests to simulate product use for the purposes of user need investigation, concept exploration/selection/refinement, requirements development, use-related risk identification, and formal usability validation with intended users.
• Support product definition for new products and platforms by applying “systems thinking”, user centered design, and development methodologies.
• Conduct user and customer research activities to identify user requirements and translating those insights into design solutions.
• Support the creation of technical documentation for products such as User manuals, IFUs and Quick Reference Guides, Training and Marketing Collateral.
• Collaborate with R&D teams to optimize designs in consideration of use error risk and overall usability, and support the identification, analysis, and evaluation of use-related risk and development of risk controls.
• Ensure that usability engineering plans, processes, and activities efficiently address requirements in order to maximize product usability and use-related safety and achieve deliverables on the project schedule. Manages outside suppliers for e.g., participant recruiting, third-party testing companies, and research facilities.
• Conduct interviews with end users and stakeholders to help our team develop interview data into deep insights and design inputs.
• Research studies, white papers, and other literature regarding human capabilities which help our collaborators define user needs, requirements, and specifications that drive the product design.
• Participate in design reviews and design FMEA analysis.
• Maintain meticulous records of projects and program issues, risks, decisions, schedules.
• Ensure project and documentation compliance to applicable standards and guidance and keeping current on new developments in human factors engineering standards, policies.
• Coach less experienced engineers on Human Factors Engineering methods, standards, and documentation.

Required Skills/Abilities

• Familiarity with IEC 60601-1-6, IEC 62366, and FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices.
• Ability to manage suppliers and consultants on various aspects of usability and clinical testing.
• Ability to communicate effectively and manage health care providers undergoing usability and clinical testing.
• Demonstrated ability to provide technical leadership for human factors engineering projects, understanding of user centered design, heuristic evaluations, design of experiments, statistical analysis, HFE requirements, and standards.
• Understanding of design requirements for development, validation, and verification of medical products.
• Strong written and verbal communication skills.
• Must meet vendor credentialing requirements to enter hospitals and other healthcare facilities.