Senior Human Factors Engineer

Intuitive•Sunnyvale, CA

About The Position

The Senior Human Factors Engineer works with designers, clinical engineers, and technical product managers to guide the development of new products that are safe and easy to use. The role conducts user research, characterizes use-related risks, and tests usability before product launch. It has primary responsibility for usability risk analyses and final usability validation studies, and collaborates with the regulatory group on usability engineering documentation for medical-device submissions. The position represents the Human Factors function on project teams, coordinates activities across projects and subsystems, and manages usability engineering schedules and status. It also mentors junior colleagues, supports a human-centered design approach across the organization, and advises management on applicable regulations, best practices, and possible process improvements.

Requirements

Bachelor’s degree or higher in Human Factors Engineering, Cognitive Psychology, Computer Science with an HCI emphasis, Human Centered Design, or a related field.
At least 8 years of relevant Human Factors or Usability Engineering experience in hardware product development.
Ability to lead usability engineering activities, including establishing usability requirements and creating usability risk analyses, test protocols, and test reports for complex, software-controlled electromechanical medical devices.
Ability to interact with customers in a highly professional manner.
Ability to analyze and synthesize large quantities of information into usable communications.
Strong ability to write accurate, clear, and concise protocols, reports, and operating procedures in a timely manner.
Excellent verbal communication and presentation skills.
Ability to work across organizational groups and management levels, including engineering, marketing, clinical engineering, and regulatory teams.
Excellent collaboration skills.
Ability to apply user-centered design and usability engineering principles to product research, development, and design.
Ability to travel domestically and internationally up to 25%.

Nice To Haves

Master’s degree.
Experience in the medical-device industry or a similar regulated industry.

Responsibilities

Collect and synthesize information about user interactions through interviews, simulations, direct observations, task analyses, and persona development.
Present findings from field observations, research, and usability testing.
Contribute to user-interface designs by recommending design changes that mitigate use errors and improve usability.
Assist with creating and revising user-interface requirements documents.
Analyze complaints about products on the market, update usability risk assessments, and escalate usability-related issues as needed.
Design, conduct, and report usability tests throughout product development, from early prototypes through formal FDA-mandated validation testing.
Write and execute usability test protocols, analyze test data, and write test reports.
Develop validation strategies for updates to existing products.
Lead the creation and updating of usability risk analyses.
Maintain traceability among use risks, mitigations, and validation test cases.
Promote a human-centered design approach across the organization.
Represent Human Factors on core teams for large projects and coordinate human factors activities across projects involving multiple subsystems.
Manage usability engineering activities within development projects and provide schedules and status updates to technical product managers and engineering project managers.
Mentor junior human factors engineers and others in usability engineering methods, best practices, and Intuitive product development processes.
Prepare and review documentation for regulatory agencies and notified bodies, and provide answers, rationale, and justification in response to questions.
Stay current on medical-device human factors regulations and best practices, including IEC 62366, AAMI HE75, and FDA guidance, and advise management about process improvements and regulatory issues.