Senior Human Factors Engineer

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Intuitive Surgical, Inc. in Sunnyvale, CA is seeking a Senior Human Factors Engineer to inform the development of safe, usable medical devices.

You will conduct user research, analyze use-related risks, and lead usability testing across product development cycles, ensuring ergonomics and safety are built in from concept through validation. Collaborate with design, clinical, and regulatory teams to create usability risk analyses and documentation for FDA submissions, mentor junior engineers, and

Qualifications

• Minimum BS in Human Factors Engineering, Cognitive Psychology, Computer Science with HCI emphasis, Human Centered Design, or related field. MS strongly preferred.
• Minimum 8+ years relevant HF/Usability Eng experience in hardware product development.
• Experience in medical device or similar regulated industry is a plus.
• Lead usability engineering activities: establish requirements, create risk analyses, test protocols and reports for complex devices.
• Interface with customers professionally.
• Analyze and synthesize large information into usable communications.
• Strong ability to write accurate, clear documentation.

Responsibilities

• Collect and synthesize information on how users interact with products via interviews, observations, and task analyses.
• Present results of field observations, research, and usability testing.
• Lead design recommendations to mitigate use errors and revise UI requirements documents.
• Analyze complaints and update usability risk assessments and related issues.
• Design, execute, and report usability tests across development stages from prototypes to validation.
• Maintain traces between use risks, mitigations, and validation test cases.

Skills

HF Engg

Regulated devices

User research

Usability testing

Regulatory liaison

Education

Bachelor's in HF Engg or related

MS preferred

Job description

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

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 update 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

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,