Human Factors Design Engineer

Job Description

Primary Function of Position

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 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.
• 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.

Qualifications

Required Skills and Experience

• 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.

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 25%).
• Primarily office-based set schedule working model.

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.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

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 will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

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.