Senior Human Factors Engineer

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive is seeking a Senior Human Factors Engineer to guide development of safe and user-friendly medical devices. You will lead user research, perform use-related risk analyses, and conduct usability validation studies to support regulatory submissions.

The role requires collaborating with designers, clinical engineers, and product managers across the development lifecycle, mentoring junior staff, and maintaining strong usability engineering processes within the organization.

Qualifications

Responsibilities

• Collect and synthesize information on how users interact with Intuitive products through 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 tests at various stages of product development, from early prototypes to 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 and others 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 and advise management regarding potential improvements to internal processes and regulatory issues related to usability engineering.

Job description

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 escalato 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.