Job Description

Primary Function of Position:

As part of the Intuitive UX Group (User Experience), The Sr. Human Factors Engineer works closely with fellow UX team interaction designers, visual designers and industrial designers. Within the project team, the Sr. Human Factors Engineer collaborates with clinical engineers, system and software engineers, technical product managers, among other important functional teams. The Sr. Human Factors Engineer is a key contributor to inform and guide development of new products, and ensure that those products are feasible, viable and desirable.

As member of new and sustaining product-development project teams, the Sr Human Factors Engineer drives as a key stakeholder within a creative and structured process to conduct user research, examine and characterize use-related risks, and conduct usability testing of products prior to launch. They have primary responsibility for evaluating product designs with end-user test participants, creating usability risk analyses, and conducting final usability validation studies and reports. The Sr. Human Factors Engineer also works closely with the regulatory, quality and design controls groups to create the usability engineering documentation required for submission to medical device regulatory agencies.

Responsibilities:

Research:

• Plan, collect and synthesize detailed insights on how users interact with Intuitive products through various techniques including interviews, simulations, direct observations, task analyses, and persona development.
• Support project-based and advanced longitudinal-research regarding cognitive/behavioral and ergonomic human factors topics.

Design:

• Contribute to workflow and user interface designs, and negotiate design recommendations to mitigate use errors and improve usability.
• Develop usability requirements driving user interface design, training and labeling.
• Assist creation and revision of user-interface requirements documents.
• Advocate highly and consistently for the clinical caregiver experience for safety and usability, with understanding of the nuance and balance of user/customer needs and business needs.

Test:

• Design, execute, and report on usability (human factors) evaluations and tests at various stages of product development from early prototypes to formal External Standards-mandated validation testing in US and OUS market environments.
• Interface and associate with end-user customers in multiple international markets to gather design insights in a highly professional manner, during complex workflow-oriented usability testing and user research activities.

Analyze:

• Write and revise highly accurate, clear, and concise usability engineering documents in a timely manner for multiple projects. (i.e. task analysis, usability risk analysis, external complaints summaries, use specifications, test reports/root cause analyses).
• Compile, organize and assess results of field observations and research, surveys, and usability testing into transferable data formats.
• Synthesize complex information into internal communications and presentations for product teams and broader organization leadership audiences.
• Prepare and review documentation for submission to regulatory agencies and notified bodies, including supporting the response to questions for additional justification and rationale.

Sustain and Improve:

• Examine complaints from on-market products, update usability risk assessment, and escalate usability-related issues as necessary.
• Keep current of MDR 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.

Collaborate:

• Drive the efforts required to create and update usability risk analyses for Intuitive Surgical products.
• 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 team colleagues), and others in organization in usability engineering methods and best practices, as well as Intuitive product development processes.

Qualifications

Skill/Job Requirements:

• Minimum Education: BS in Human Factors Engineering, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field. MS highly preferred.
• Minimum of 8 years of related experience with a Bachelor’s degree (in engineering); or 6 years and a Master’s degree; or a relevant PhD with 3 years experience; or equivalent experience with human factors/biomedical devices.
• Experience in medical device product development within a design controls process (or similar highly regulated industry) is of significant value.
• Excellent verbal communication and presentation skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms)
• Experience working with Digital project collaboration tools is appreciated. (e.g. Mural or Batterii, Smarsheets etc)
• Demonstrated ability to apply user-centered design and usability engineering principles to product research, development, and design in a fast-paced product development environment.
• Demonstrated ability to collaborate with and across various groups and levels of management within the organization, including other engineering groups, marketing, clinical engineering, and regulatory to solve complex usability issues involving detailed risk analysis.
• Ability to travel internationally as well as domestically (up to 20%; 25-30%) 1 week a quarter: local hospital or customers in other parts of the country.