- Work with Human Factors Research partners to establish and support strategy for usability research within the BU.
- Forecast planning and budgeting for needed research efforts with the business unit, including estimates for needed resources and equipment.
- Plan and support project-based and advanced longitudinal-research regarding cognitive/behavioral and ergonomic human factors topics.
- Mentor and support HF team members in development of usability requirements driving user interface design, training and labeling.
- Collaborate with cross-functional partners to ensure integration of usability engineering into design input.
- Consistently advocate for clinical caregivers' safety and usability, balancing user needs with business needs. Advocate with empathy.
- Plan and define budgeting and resource needs for usability evaluation and testing efforts within the Business Unit.
- Support usability evaluations and tests, reporting to leadership during product development stages. The Human Factors Manager will oversee testing for all BU projects, from prototypes to formal validation tests. Testing will occur in both US and OUS market environments.
- Engage with customers worldwide to collect design feedback professionally through usability testing and user research in complex workflows.
- Make sure usability engineering documentation is accurate, clear, and delivered on time for various projects. This includes task investigation, risk scrutiny, complaint summaries, use specifications, and test reports.
- Synthesize complex information into internal communications and presentations for product teams and broader organization leadership audiences.
- Prepare and review documents for regulatory submission. Support responses to questions as needed. Submit to agencies and notified bodies.
- Manage team efforts in complaints investigation from on-market products, update usability risk assessment, and escalate usability-related issues as necessary.
- Stay updated on MDR regulations and best practices for medical device human factors. Advise management on improving internal processes and regulatory issues.
- Manage the efforts required to create and update usability risk analyses for Intuitive Surgical products.
- Represent Human Factors as the main contact for HF input in regulatory submissions and resolving project conflicts. This includes coordinating between teams with conflicting needs.
- Plan and manage human factors efforts across projects involving several sub-systems.
- Coordinate HF team's testing needs, supplies, and equipment. Work closely with Platform team leaders to prepare test articles.
Replace "leaders" with "managers" in the above sentence. - Mentor human factors engineers. - Train interns and junior team members. - Teach usability engineering methods. - Share best practices in Intuitive product development.
- Minimum education required: Bachelor's in Human Factors Engineering, Cognitive Psychology, Computer Science with HCI focus, or related field. Master's preferred.
- Minimum 5 years relevant Human Factors/Usability/Human Performance Engineering experience in hardware product development industry.
- 3 years or more experience as a manager in a product development role.
- Experience in developing medical devices within a regulated industry like healthcare is necessary.
- Demonstrated experience in HF (UX) and User Research project management
- Proven success in regulatory submissions, including Usability Engineering File & Summative Usability Validations following External Standards.
- Great speaking skills in prestigious setting, using email, text, video, and messaging for communication.
- Experience working with Digital project collaboration tools is appreciated. (e.g. Mural or Batterii, Smarsheets etc)
- I can advocate for user-centered design and usability engineering in fast-paced product development. I promote these values effectively.
- Proven skill collaborating with different leadership levels and functions within the organization to address usability issues. This includes engineering groups, marketing, clinical engineering, and regulatory teams.
- Ability to travel both within the country and internationally, up to 20% of the time, for work purposes. Travel required for visiting customers and local hospitals.
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Human Factors Manager - Sunnyvale, United States - Intuitive
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 their most 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 Description
Primary Function of Position:The Human Factors Manager collaborates with team members, designers, and engineers. They also work with cross-functional partners to support Human Factors team development. The manager represents the Human Factors function in business units for safety, usability, and regulatory compliance. They support and ensure execution of Usability Engineering initiatives and process activities within product development teams.
The Human Factors Manager drives product development teams, plans usability activities, and supports direct reports within the HF team. They collaborate with regulatory and design groups to ensure proper usability engineering strategy implementation.
This Human Factors Manager role can be assigned to four business units at Intuitive. They include Digital, ION, Da Vinci Multiport RAS, and Da Vinci Single Port RAS. The manager will report to Senior Human Factors Leadership, supporting all business units.Roles and Responsibilities:
Research:
Skill/Job Requirements:
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.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
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.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
