Intuitive Surgical Careers
Manager, Human Factors Engineering - Digital
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 183440
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
The Manager, Human Factors Engineering - Digital works closely with digital designers, 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 studies. The Manager, Human Factors Engineering - Digital also works closely with the regulatory group to create the usability engineering documentation required for submission to medical device regulatory agencies. The Digital Human Factors Engineer Manager focuses primarily on the customer experience as they interact with software or a website, other product, or service.
The Manager, Human Factors Engineering – Digital interacts and evaluates what makes a website or other product/service work well and what can improve the experience of the end user.
Roles and Responsibilities:
• Collect and synthesize detailed information on how users interact with Intuitive Surgical’s digital products and/or services 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, Service, and Data & Digital Development organizations.
• 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 similar on-market products and update usability assessments 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, where needed. 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 analyses for Intuitive Surgical’s digital 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 digital/service projects.
• Coordinate human factors efforts across projects involving several sub-teams.
• Manage usability engineering activities within development projects and provide schedules and status to product managers and project managers.
• Prepare and review documentation for submission to regulatory agencies and notified bodies, as needed. 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.
• 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 5 years relevant Human Factors/Usability Engineering experience in software, digital, and/or data 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 analyses, test protocols, and test reports) for a complex, software and services
• 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%)
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.