At Intuitive, 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. Our mission is our guiding force; our culture is the DNA that makes us unique.
As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges.
We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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 help to advance the world of minimally invasive care.
Primary Function of Position: The Sr. Human Factors Engineer works closely with interaction designers, clinical engineers, and technical product managers to inform and guide development of new products, and ensure that those products are safe and easy to use. As part of new product development projects, they conduct user research, analyze and characterize use-related risks, and conduct usability testing of products prior to launch. They have primary responsibility for creating usability risk analyses and conducting final usability validation studies. The Sr. Human Factors Engineer also works closely with the regulatory group to create the usability engineering documentation required for submission to medical device regulatory agencies.
Roles and Responsibilities:
Collect and synthesize detailed information on how users interact with Intuitive products through various techniques including interviews, simulations, direct observations, task analyses, and persona development.
Present results of field observations, research, and usability testing to the New Product Development organization.
Contribute to user interface designs by negotiating design recommendations to mitigate use errors and improve usability. Assist creation and revision of user-interface requirements documents.
Analyze complaints from on-market products and update usability risk assessment and escalate usability-related issues as necessary.
Design, execute, and report on usability (human factors) tests at various stages of product development from early prototypes all the way through formal FDA-mandated validation testing. Write and execute usability test protocols. Analyze test data and write test reports. Develop validation strategies for projects involving updates to existing products.
Lead the efforts required to create and update usability risk analyses for Intuitive Surgical products.
Maintain traces between use risks, mitigations, and validation test cases.
Reinforce a human centered design approach across the organization.
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 others in organization in usability engineering methods and best practices, as well as Intuitive product development processes.
Lead or support the development of usability engineering processes within the multiport engineering group, including the creation and maintenance of department operating procedures, test plan templates, etc.
Prepare and review documentation for submission to regulatory agencies and notified bodies. Answer questions and provide additional justification and rationale to any questions received.
Keep abreast of 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.
Minimum Education: BS in Human Factors Engineering, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field. MS strongly preferred.
Minimum 8 years relevant Human Factors/Usability Engineering experience in hardware product development industry
Experience in medical device, or similar regulated industry, a significant plus
Ability to lead usability engineering activities (i.e. establishing usability requirements; creating usability risk analyses, test protocols, and test reports) for a complex, software-controlled electro-mechanical medical device
Ability to interface with customers in a highly professional manner
Ability to analyze and synthesize large quantities of information into usable communications
Superior ability to write accurate, clear, and concise protocols, reports, operating procedures, etc. in a timely manner
Excellent verbal communication and presentation skills
Ability to work with and across various groups and levels of management within the organization, including other engineering groups, marketing, clinical engineering, and regulatory. Excellent collaboration skills.
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 20%; 25-30%) 1week a quarter: local hospital or customers in other parts of the country.
Employer will assist with relocation costs.
Additional Salary Information: we offer great compensation package and relocation assistance
Internal Number: 211295
About Intuitive Surgical
Intuitive Surgical, Inc. (NASDAQ: ISRG) is a global technology leader in minimally invasive robotic-assisted surgery. The Company's da Vinci® Surgical System enables surgeons to operate minimally invasively through a few small incisions or the belly button from a nearby ergonomic console. The da Vinci System features a magnified 3D HD vision system and tiny wristed instruments that bend and rotate far greater than the human hand. As a result of this technology, da Vinci enables surgeons to operate with enhanced vision, precision and control.