Senior Human Factors Engineer

Job description

Primary Function The Senior Human Factors Engineer works closely with designers, clinical engineers, and technical product managers to inform and guide the development of new products and ensure that those products are safe and easy to use. As part of new product development projects, they conduct user research, analyze and characterize use-related risks, and conduct usability testing of products prior to launch. They have primary responsibility for creating usability risk analyses and conducting final usability validation studies.

The Senior Human Factors Engineer also works closely with the regulatory group to create the usability engineering documentation required for submission to medical device regulatory agencies.

Roles & Responsibilities

Collect and synthesize detailed information on how users interact with Intuitive products through various techniques including interviews, simulations, direct observations, task analyses, and persona development. Present results of field observations, research, and usability testing. Contribute to user interface designs by negotiating design recommendations to mitigate use errors and improve usability. Assist creation and revision of user-interface requirements documents.

Analyze complaints from on-market products and update usability risk assessment and escalate usability-related issues as necessary. Design, execute, and report on usability (human factors) tests at various stages of product development from early prototypes all the way through formal FDA-mandated validation testing. Write and execute usability test protocols. Analyze test data and write test reports. Develop validation strategies for projects involving updates to existing products.

Lead the efforts required to create and update usability risk analyses for Intuitive products Maintain traces between use risks, mitigations, and validation test cases. Reinforce a human centered design approach across the organization. Represent the Human Factors function on core teams for large projects. Coordinate human factors efforts across projects involving several sub-systems. Manage usability engineering activities within development projects and provide schedules and status to technical product managers and engineering project managers.

Mentor junior human factors engineers (e.g. interns) and others in organization in usability engineering methods and best practices, as well as Intuitive product development processes. Prepare and review documentation for submission to regulatory agencies and notified bodies. Answer questions and provide additional justification and rationale to any questions received. Keep abreast of regulations and best practices for medical device human factors (e.g.

IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices) and advise management regarding potential improvements to internal processes and regulatory issues related to usability engineering.

Qualifications

Qualifications

Skills, Experience, Education, & Training: Minimum BS in Human Factors Engineering, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field. MS strongly preferred.

• Minimum
• 8+ years relevant Human Factors/Usability Engineering experience in hardware product development industry Experience in medical device, or similar regulated industry, a significant plus
• Ability to lead usability engineering activities (i.e. establishing usability requirements; creating usability risk analyses, test protocols, and test reports) for a complex, software-controlled electro-mechanical medical device
• Ability to interface with customers in a highly professional manner
• Ability to analyze and synthesize large quantities of information into usable communications Superior ability to write accurate, clear, and concise protocols, reports, operating procedures, etc. in a timely manner
• Excellent verbal communication and presentation skills
• Ability to work with and across various groups and levels of management within the organization, including other engineering groups, marketing, clinical engineering, and regulatory.

Excellent collaboration skills. Ability to apply user-centered design and usability engineering principles to product research, development, and design Ability to travel internationally as well as domestically (up to 25%)