UI/Human Factors Engineer 3

Role: Human Factors Design Controls Engineer

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 shelp to advance the world of minimally invasive care.

Primary Function of Position: As part of the Intuitive Human Factors team, The Human Factors Design Controls Engineer works closely with fellow HF team members and department leadership, as well as collaborates with, clinical engineers, interaction designers, system and software engineers, product managers, project management and technical publications, in addition to regulatory and quality. The Human Factors Design Controls Engineer is a key contributor to inform, guide development of, and maintain usability engineering documentation produced during projects within Design Controls. This role supports the Human Factors Engineering team with expertise in design controls and content creation in tools such as Polarion and Agile, and helps to create the usability engineering documentation required for submission to global medical device regulatory agencies.

This role provides dedicated support and subject matter expertise guidance to the broader human factors engineering team serving all business units and reports to a Sr. Human Factors staff member.

Roles and Responsibilities:

Assist in planning and organization for multiple product risk assessment document remediation efforts running in parallel for a set grouping of risk analysis documents

Analyze existing risk analysis documents for remediation into new risk assessment document formats, including editing and revising risks per Intuitive risk management process and standards.

Support Quality Engineering in collating, editing and improving large amounts of risk line items using efficient methods within a standardized methodology for document remediation.

Assess and prioritize plans for working on multiple documents in parallel, according to emergent needs of document content that may require mode or less effort to refine and improve content.

Skill/Job Requirements:

Minimum of 5 years of related experience with a bachelor s degree

Relevant work experience in human factors engineering, clinical engineering, product design engineering, quality engineering, design controls, risk management and medical device product development.

Strong experience working with design controls project collaboration tools is required. (e.g. Polarion, Agile, Smartsheets etc.).

Knowledge and experience working within medical device design controls process and documentation methodologies, compliant with medical device quality management system regulation (QSMR 13485)

Demonstrable knowledge in medical device risk analysis principles and practices, and risk analysis documentation according to ISO14971 and 62366.

Ability to collaborate with and across various groups and levels of management within the organization.

Strong verbal communication and data analysis skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms).

Ability to travel domestically (up to 10%) to onsite locations if remote.