Human Factors Design Engineer

Intuitive•Sunnyvale, CA

About The Position

Primary Function of the Position As part of the Intuitive Human Factors team, the Senior Human Factors Engineer works closely with designers, clinical engineers, system and software engineers, technical product managers, regulatory affairs, and other important functional teams. The Senior Human Factors Engineer is a key contributor in informing and guiding development of new products, and ensuring that those products are feasible, viable and desirable. The Human Factors Design Engineer will serve as the Human Factors (HF) Lead on new and/or sustaining product development teams within Intuitive. Within the project team, the Human Factors Design Engineer (HFDE), works closely with designers, clinical engineers, system and software engineers, product managers, regulatory affairs, and other cross functional teams. They have primary responsibility to conduct research to gain a deep understanding of users, uses and use environments; perform task analysis, analyze and characterize usability considerations and use-related risks; conduct iterative formative evaluations with end-users to realize the impact of design concepts on user workflow, behavior and performance; translate user needs into usability requirements to inform design; and be accountable for final usability validation. The Human Factors Design Engineer also works closely with the regulatory, quality and design controls teams to define the submission strategy from HF perspective and be accountable for the usability engineering documentation required for submission to medical device regulatory agencies. The Human Factors Design Engineer position reports to a Manager within the broader Human Factors (HF) organization at Intuitive.

Requirements

Minimum 3-5 years relevant HF experience in industry.
Excellent communication (verbal, written, and formal presentation) and collaboration skills.
Ability to analyze and synthesize large quantities of information into usable communications.
Ability to work with and across various groups and levels of management within the organization, including other engineering groups, marketing, clinical engineering, and regulatory.
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%).
Minimum BS or MS in Human Factors Engineering, Cognitive Psychology, Biomedical Engineering, Human-Computer Interaction, Human-Centered Design, or a related field, with emphasis in Interaction Design and User Interface Design.

Nice To Haves

Experience in medical device, or similar regulated industry.
Experience with design engineering in product development.
Ability to empathize with people and to understand the human condition.
Ability to interface with customers in a highly professional manner.

Responsibilities

Research: Plan, collect and synthesize data to generate insights on how and why users interact with Intuitive products through various techniques including interviews, simulations, direct observations, workflow labs, human performance research, persona development, usability testing, mixed methods research, discovery from known use problems, etc.
Represent Intuitive during interactions with end-user clinicians and customers in multiple international markets to gather design insights in a highly professional manner, during formative research activities.
De-risk design strategies by identifying root causes and conduct root cause analyses that account for human performance influencers underlying the user experience
Design: Analyze, define and evaluate workflow and user interface designs.
Negotiate design recommendations and improvements to prevent hazardous situations related to use errors and improve usability.
Accountable for establishment, authoring and management of usability design inputs.
Translate findings from formative research activities into insights that are used to define evidence- based user requirements and user interface design requirements to inform user interface design, labeling and training.
Develop conceptual prototypes that reflect performance influencers for showcasing and translating for stakeholders
Advocate strongly 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 evaluations at various stages of product development, from explorative co-creation of design with end users, to formal usability studies to evaluate usability and risk with prototypes of varying degrees of fidelity.
As HF Lead on projects, accountable for summative usability validation and design validation of usability design inputs.
Collaborate closely with internal human factors partners to define and execute validations.
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, use specifications, test reports and 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 from regulatory agency reviewers for additional justification and rationale.
Sustain and Improve : Collaborate closely with internal human factors partners to analyze 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: Coordinate human factors efforts across projects involving several sub-systems.
Manage usability engineering activities within development projects and provide schedules and status to product managers and engineering project managers.