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Senior Director, Human Factors

Company: Intuitive
Location: Sunnyvale
Posted on: May 16, 2022

Job Description:

Company DescriptionAt 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 theirmost 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 DescriptionPrimary Function of Position:

  • The Senior Director of Human Factors leads the human factors (usability engineering) function at Intuitive Surgical. He or she is responsible for building and maintaining the human factors staff and processes to make the team successful.
  • The Human Factors team works within the new product development organization to help develop highly effective surgical robotic systems, instruments, accessories, and software that ultimately improve the clinical outcomes 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 desirable, 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 Senior Director of Human Factors 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 Senior Director 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. -Roles and Responsibilities:
    • Recruit, develop, and retain high performing human factors staff.
    • Mentor and coach staff with a wide range of technical and leadership capabilities, from entry level to Principal Engineer and manager to director. Implement robust onboarding and career development pathways for staff that empower individuals to perform at their highest capacity.
    • Direct HF strategy across products portfolio by understanding business goals and linking design directions, product architecture, and processes to corporate strategy.
    • Ensure the department is following state of the art processes. Develop, refine and monitor HF policies, systems, procedures and templates to ensure alignment to current best practices and industry standards to meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business.
    • Advise senior leadership on and advocate for solutions that support both end-user goals and long-term product visions and business strategies.
    • 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 package, and respond to questions from regulatory agencies.
    • 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.
    • Participate in audits, respond to questions, and review submission materials as the technical authority on human factors. -
    • Be a vocal internal and external advocate for proper UX process and integration. Teach UX process and understanding of customers to cross-functional project teams and leaders (and internal team members as needed).QualificationsSkill/Job Requirements:
      • Must be a selfless leader who inspires trust and commitment within their team and in the broader organization through integrity, passion, and professional excellence.
      • M.S. or Ph.D. in Human Factors Engineering, Cognitive Psychology, Systems Engineering or Computer Science with human-computer interface (HCI) emphasis, or related field.
      • Minimum of 15 years of relevant human factors/usability engineering experience in hardware product development industry.
      • Minimum 10 years of relevant user research and/or UX experience.
      • Minimum 10 years of experience in the medical device industry, or similar regulated industry.
      • 8 years or more experience as a manager required, in a product development role is strongly preferred.
      • 5 years or more experience working with complex HW/SW systems is strongly preferred.
      • Ability to lead team to practical solutions that satisfy regulatory, engineering, and business needs with limited resources and time.
      • Ability to effectively support 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 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 up to 40% - -Additional InformationAll your information will be kept confidential according to EEO guidelines.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. Shift : Day Travel : 50% of the timeTravel Requirements:50% of the time Shift:Day

Keywords: Intuitive, Sunnyvale , Senior Director, Human Factors, Executive , Sunnyvale, California

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