Overview
Skills
Job Details
Primary Function of Position:
As part of the Intuitive Human Factors team, The Sr. 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 Sr. 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. Responsibilities are focused on comprehensive and timely implementation of summaries of known use problems reports, task analysis, risk analysis, design inputs and usability validation test cases. 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 Manager. For reference, a brief description of each of the business units is as follows.
Digital Business Unit: Work within the HF team on the Digital products and Services platform focuses on User Experience with software and web-based products that are integrated with all the Intuitive products.
ION System Business Unit: The HF team within the ION Platform supports development of an emerging and developing product for systems, software and instruments with specialized users in the pulmonary/ endoluminal treatment modalities.
Da Vinci Multiport RAS Business Unit: HF teams in the Multiport group support a wide array of multi-generational products and services touching all aspects of the product portfolio including the robotic systems, instruments and accessories, focused on the user interface, workflow and safety.
Da Vinci Single Port RAS Business Unit: The HF team in the Da Vinci SP platform work in similar ways as the Multiport team, supporting new and sustaining product development on a growing and emerging product platform exploring and expanding into new RAS treatment areas.
Roles and Responsibilities:
Research:
Support definition, release and maintenance of task analyses and comparative task analyses documentation. This important work is needed to preserve continuity across many-level task analyses documents.
Generate and support maintenance of known use problem documentation (similar to quality data review documentation).
Support definition and release of Usability Engineering Plan documents.
Design:
Support definition, release and maintenance of usability related risk documentation.
Support definition, release and maintenance of usability related design inputs documentation.
Create and maintain tracing documentation.
Test:
Help guide Human factors team in best practices for definition of validation test cases.
Support proper tracing between task analysis, risks, design inputs and test cases.
Analyze:
Identify and resolve tracing conflicts and design input orphans in tracing between risks and design inputs/risk controls
Sustain and Improve:
Analyze complaints from on-market products, update usability risk assessment, and help 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.
Support continuous improvement of usability engineering process and contribute to improvements with subject matter expertise on best practices related to design controls.
Collaborate:
Lead the efforts required to create and update usability risk analyses for Intuitive Surgical products.
Represent the Human Factors Design Controls function on core teams for large projects.
Coordinate human factors efforts across projects involving several sub-systems.
Mentor junior human factors engineers (e.g. interns and team colleagues), and others in organization in design control methods and best practices, as well as Intuitive product development processes.
Qualifications
Skill/Job Requirements:
Minimum Education: BS in Human Factors Engineering, Biomedical Science or Engineering, Systems Engineering, Quality Engineering, Information and Data Science, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field.
Minimum of 8 years of related experience with a bachelor s degree (in engineering, design controls, medical device product development or related field).
Excellent verbal communication and presentation skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms).
Experience working with Digital project collaboration tools is appreciated. (e.g. Polarion, Agile, Python, Smartsheets etc.).
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 travel internationally as well as domestically (up to 15%) to onsite locations if remote.
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.