Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 201009
Primary Function of Position:
The Manager, Human Factors Engineering leads the human factors (usability) engineering function at Intuitive Surgical. He or she is responsible for building and maintaining the human factors engineering staff and processes to make the team successful.
The Human Factors Engineering team works within the new product development organization to help develop highly effective diagnostic and surgical robotic systems, instruments, accessories, and software that ultimately improve the clinical outcome for patients. The Human Factors group conducts user research, analyzes and characterizes use-related risks, provides input on design to reduce use-related errors, and conducts formative and summative usability testing of products prior to launch. As part of the new product development organization, they work closely with design engineers, interaction designers, clinical engineers, and product managers to inform and guide development of new products, and ensure those products are safe and easy to use. After product launch, the Human Factors group works with post-market surveillance to monitor, investigate, and respond to use-related safety issues.
The Human Factors Engineering Manager provides leadership through in-depth knowledge of human factors design principles and usability testing methods, as well as a keen understanding of the product development process in the medical device industry. The manager is responsible for planning and executing all human factors engineering activities needed to support the development of world-class products, and to meet the requirements of medical device regulatory agencies around the world.
- Recruit, develop, and retain high performing human factors engineering staff.
- Mentor and coach staff with a wide range of technical and leadership capabilities, from entry level to Principal Engineer. Implement robust onboarding and career development pathways for staff that empower individuals to perform at their highest capacity.
- Organize and direct the work of human factors engineering staff and outside consultants to effectively and efficiently support product development efforts within the company. Product development deliverables include, but are not limited to:
- Usability engineering files
- Task analyses
- Usability risk analyses
- Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs
- Validation test reports and human factors engineering reports
- Develop collaborative working relationships with other functions within the product development organization such as design engineering, interaction design, clinical development engineering, and product marketing.
- Lead the team’s collaborative work with the regulatory group to develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies and auditors.
- Ensure the company’s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business.
- Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advise management regarding potential improvements to internal processes and regulatory issues related to human factors engineering.
- Lead human factors activities related to on-market products, in order to effectively understand and respond to use-related safety issues.
- Represent Intuitive Surgical in meetings with regulatory agencies and at human factors professional meetings and conferences.
- Develop the team’s user research capabilities. Lead human factors engineering team to collect and synthesize detailed information about how users interact with Intuitive Surgical’s products through various techniques including interviews, simulations, direct observation at hospitals, task analysis, and personas.
- Present results of field observations, research, and usability testing to the New Product Development organization.
- Contribute to user interface designs by providing guidance, ideas, and feedback to interaction designers and developers. Assist with creation and revision of user-interface requirements documents.
- Must be a selfless leader who inspires trust and commitment within their team and in the broader organization through integrity, passion, and professional excellence.
- B.S., M.S. or Ph.D. degree in in Human Factors Engineering, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, or related field.
- 2 years or more experience as an engineering manager in a product development role is strongly preferred.
- Minimum of 5 years of relevant human factors/usability engineering experience in hardware product development industry.
- Experience in medical device, or similar regulated industry.
- Ability to lead team to practical solutions that satisfy regulatory, engineering, and business needs with limited resources and time.
- Ability to effectively direct the activities of a human factors/usability engineering team supporting multiple simultaneous development projects, many of which involve complex, software-controlled electro-mechanical systems.
- Ability to work seamlessly across various departments (e.g. engineering, marketing, regulatory) and levels of management within the organization. Excellent collaboration skills.
- Excellent verbal communication and presentation skills. Ability to present work of human factors engineering team to executive management.
- Ability to interface with customers in a highly professional manner
- Superior ability to write and edit accurate, clear, and concise protocols, reports, operating procedures, and to review the writing of staff to ensure consistent, high quality output.
- Ability to apply user-centered design and human factors/usability engineering principles to product research, development, and design
- Ability to travel internationally as well as domestically (~25%)