Sr. Human Factors Design Engineer - Future Forward Team

Job Description

Primary Function

The Senior Human Factors Design Engineer works closely with interaction designers, clinical engineers, and technical product managers to inform and guide 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 Design 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 to the New Product Development organization.
• 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 Surgical's 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.
• Lead or support the development of usability engineering processes within the Future Forward Research group, including the creation and maintenance of department operating procedures, test plan templates, etc.
• 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.