Sr. Human Factors Engineer - Field Services

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of the Position

As part of the Intuitive Human Factors Team, the Sr. Human Factors Engineer works closely with human factors colleagues and cross functional partners including clinical engineers, system and software engineers, designers, field service engineers, technical product managers, regulatory affairs, among other important functional teams. The Sr. Human Factors Engineer is a key contributor to inform and guide development of new products, and ensure that those products are feasible, viable, and desirable.

As a member of new and sustaining product-development project teams, the Sr Human Factors Engineer drives as a key stakeholder within a creative and structured process to conduct user-centered design research, examine and characterize use-related risks, and conduct usability testing of products prior to launch, and track and iterate on designs once projects are in the field. They have primary responsibility for evaluating product designs with end-user test participants, and to conduct qualitative research to gain a deep understanding of users, uses, and use environments; create user requirements; conduct concept evaluations to realize the impact of design concepts on user workflow, behavior and performance; translate user needs into risk analyses, and conduct final usability validation studies and reports. The Sr. Human Factors Engineer also works closely with the regulatory, quality and design controls groups to create 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, and persona development.
• Support project-based and advanced longitudinal-research regarding cognitive/behavioral and ergonomic human factors topics.
• Perform all aspects of research studies including study design, instrument development, data collection (both desktop and in the field) and management, quantitative and qualitative data analysis, reporting and dissemination, and communication and collaboration with partners.
• Create actionable insights for improving products and services based on results of internally and externally guided research.
• Examine and characterize usability considerations, including physical, cognitive, social, and organizational aspects of human factors that influence performance while interacting with Intuitive products.
• Draft usability requirements.

Design:

• Contribute to workflow and user interface designs, and negotiate design recommendations to mitigate use errors and improve usability.
• Develop usability requirements driving user interface design, training, and labeling.
• Assist creation and revision of user-interface requirements documents.
• Advocate highly 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 (human factors) evaluations and tests at various stages of product development from early prototypes to formal External Standards-mandated validation testing in US and OUS market environments.

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, external complaints summaries, use specifications, test reports/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 for additional justification and rationale.

Sustain and Improve:

• Examine 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:

• Drive the efforts required to create and update usability risk analyses for Intuitive Surgical products.
• Represent the Human Factors function on core teams for large projects.
• Coordinate human factors efforts across projects involving several sub-systems.
• Manage usability-engineering activities within development projects and provide schedules and status to technical 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.
• Track usability findings from the field and support responses to field actions.

Qualifications

Required Skills and Experience

• Experience in medical device product development within a design controls process (or similar highly regulated industry) is of significant value.
• Excellent writing, verbal, and presentation communication skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms)
• Experience with data collection tools, e.g. Qualtrics.
• Experience working with Digital project collaboration tools is appreciated. (e.g. Mural, Lucid, Smartsheets, etc.)
• Demonstrated ability to apply user-centered design and usability engineering principles to product research, development, and design in a fast-paced product development environment.
• Demonstrated ability to collaborate with and across various groups and levels of management within the organization, including other engineering groups, marketing, clinical engineering, and regulatory to solve complex usability issues involving detailed risk analysis.
• Ability to examine and synthesize large quantities of qualitative and quantitative data using QDA software and statistical software (e.g. NVivo, atlas.ti, SPSS/SAS/JMP/Stata/R).
• Ability to travel domestically and potentially internationally (up to 40%).

Required Education and Training

• Minimum Education: BS in Human Factors Engineering, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field. MS highly preferred.
• Minimum Experience: 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a relevant PhD with 3 years experience; or equivalent experience with human factors/biomedical devices.

Working Conditions

• Ability to obtain and maintain vendor credentialing approval for access to operating rooms
• Ability to be in operating rooms, surgical environments, and simulated laboratories for case observations and studies
• Potentially be exposed to hot and cold environments when supporting service engineers in unpacking or servicing robotic systems
• Compliance with all necessary vaccination requirements as mandated by the vendor credentialing process
• Ability to lift 50 lbs and move wheeled objects up to 1200 lbs

Preferred Skills and Experience

• Experience with human factors activities related to servicing of medical devices or similar equipment

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 Employment 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.

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

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 salary ranges are listed.

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 Employment Opportunity / Affirmative Action 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.

EEO and AA Policy

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.

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 salary ranges are listed.