Sr Human Factors Analyst

Intuitive Surgical Inc

Peachtree Corners, GA

JOB DETAILS
SKILLS
Analysis Skills, Association for the Advancement of Medical Instrumentation (AAMI), Best Practices, Biomedical Engineering, Building Systems, Career Development, Clinical Information Systems, Clinical Practices/Protocols, Code of Federal Regulations, Cognitive Psychology, Cross-Functional, Customer Relations, Customer/Client Research, Customer/Consumer Behavior, Data Formats, Documentation, Documentation Review, Engineering, Engineering Management, FDA (Food and Drug Administration), Government, Healthcare, Human Factors, Human-Computer Interaction, Import/Export, International Electro-Technical Commission (IEC), Interpersonal Skills, Interviewing Skills, Leadership, Licensing, Marketing, Medical Equipment, Mentoring, Multitasking, Negotiation Skills, Organizational Development/Management, Persona/Avatar Development, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Product Engineering, Project/Program Management, Prototyping, Quality Assurance Methodology, Regulations, Regulatory Submissions, Requirements Management, Research Skills, Risk Analysis, Root Cause Analysis, Schedule Development, Software Engineering, Systems Administration/Management, Systems Engineering, TCP (Transmission Control Protocol), Team Lead/Manager, Team Player, Technical/Engineering Design, Testing, Time Management, Training/Teaching, Usability Engineering, Usability Testing, User Interface (UI) Requirements, User Interface Design, User Interface/Experience (UI/UX), Willing to Travel, Workflow Analysis
LOCATION
Peachtree Corners, GA
POSTED
30+ days ago

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

Senior Human Factors Engineer Position

The Senior Human Factors Engineer will serve as the Human Factors (HF) Lead on new and/or sustaining product development teams within Intuitive. Within the project team, the Senior Human Factors Engineer (HFE), works closely with designers, clinical engineers, system and software engineers, product managers, regulatory affairs, and other cross-functional teams.

Responsibilities

  • 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
  • Be accountable for final usability validation
  • Work 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

Essential Job Duties

  • Research: • Plan, collect, and synthesize detailed insights on how users interact with Intuitive products through various techniques including interviews, simulations, direct observations, task analyses, persona development, usability testing, mixed methods research, 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 complex workflow-oriented usability testing and user research activities.
  • 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, both user requirements and design requirements to inform user interface design, labeling, and training
  • 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 • 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 with 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 • 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 • Support special projects within the Human Factors Group from team building, to skills development and career development

Required Skills and Experience

  • Minimum 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

Required Education and Training

  • 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

Working Conditions

  • Ability to travel internationally as well as domestically (up to 30%)
  • Primarily office-based set schedule working model
  • May need to move large robotic systems in buildings

Preferred Skills and Experience

  • 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

Mandatory Notices

  • U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
  • Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
  • For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We Provide

  • Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity
  • It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

About the Company

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Intuitive Surgical Inc