Human Factors Design Engineer

Intuitive; Sunnyvale (CA); On-site; USD 170,000 - 230,000; Full time

Job summary

Intuitive seeks a Senior Human Factors Engineer to lead usability research, design validation, and risk analysis for next-generation surgical robotics. You will work with designers, engineers, regulatory affairs, and product managers to ensure products are usable, safe, and compliant across international markets.

The role requires ownership of usability inputs, performing formative and summative evaluations, translating user needs into requirements, and supporting regulatory submissions with

Responsibilities

• Lead usability research and usability validation activities across product development teams.
• Translate user needs into usability requirements for interface design and training.
• Author and maintain usability engineering documents for regulatory submissions.
• Collaborate with regulatory, quality, and design control teams to define submission strategies.

Job description

Job Description

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.

Essential Job Duties

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 elevate 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.