Manager Human Factors Engineering

Primary Function:
The Human Factors Manager works closely with Human Factors team members, interaction designers, visual designers and industrial designers and collaborates with other cross-functional partners in clinical engineering, system and software engineering, product management, and program mangers among other important functional teams. The Human Factors Manager primary role is to support, inform and guide development of Human Factors team members (direct reports and adjacent HF teams), and represent the Human Factors function within and across business units as an advocate for the clinical caregiver end-users regarding safety and usability, and as representative for medical device regulatory compliance. Within product development teams and across Business Units, the Human Factors Manager supports and helps ensure successful execution of Human Factors Usability Engineering initiatives, and process activities and deliverables.

As member of new and sustaining product-development project teams, the Human Factors Manager leads as a key stakeholder within a creative and structured process to help their direct HF team plan, communicate and advocate the value of Human factors function, and execute the appropriate scale of usability engineering activities prior to launch. The Human Factors manager is responsible for the development and success of their direct reports on the Human factors team, supporting the specific business unit. The Human Factors Manager works closely with regulatory, quality and design controls groups to ensure proper implementation the usability engineering strategy and documentation required for submission to medical device regulatory agencies.

This particular role of Human Factors Manager may be assigned to any one of four related yet distinct business units (Digital, ION, Da Vinci Multiport RAS, Da Vinci Single Port RAS) that are focused on specific product platforms and/or services within Intuitive and will report directly to Senior Human Factors Leadership supporting all business units.
Roles and Responsibilities:

Research:

• 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.

Design:

• 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.
• Advocate strongly and consistently for the clinical caregiver experience for safety and usability, with understanding of the nuance and balance of user/customer needs and business needs.

Evaluate:

• Plan and define budgeting and resource needs for usability evaluation and testing efforts within the Business Unit.
• Support the execution of, and report to leadership on usability (Human Factors) evaluations and tests at various stages of product development. The Human Factors Manager will balance the testing efforts on all BU projects from early prototypes to formal External Standards-mandated validation testing in US and OUS market environments.
• Interface and associate with end-user customers in multiple international markets to gather design insights in a highly professional manner, during complex workflow-oriented usability testing and user research activities.

Growth

• Ensure accurate, clear, and concise usability engineering documentation is delivered in a timely manner for multiple projects. (i.e. task analysis, usability risk analysis, external complaints summaries, use specifications, test reports/root cause analyses).
• Synthesize complex information into internal communications and presentations for product teams and broader organization leadership audiences.
• Prepare and review documentation for submission to regulatory agencies and notified bodies, including supporting the response to questions for additional justification and rationale.

Sustain and Improve:

• Manage team efforts in complaints analysis from on-market products, update usability risk assessment, and 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.

Collaborate:

• Lead the efforts required to create and update usability risk analyses for Intuitive Surgical products.
• Represent the Human Factors function as the point of contact regarding HF input related to regulatory submissions and project related conflict resolution within project teams with differing cross-functional needs and priorities.
• Plan and manage Human Factors efforts across projects involving several sub-systems.
• Manage the needs of the HF team regarding testing materials, supplies and equipment, and communicate closely with Platform team leaders to ensure test article are ready in team for testing.
• Mentor the direct Human Factors engineers (e.g. interns and more junior team colleagues), and others in organization in usability engineering methods and best practices, as well as Intuitive product development processes.

Qualifications

Skill/Job Requirements:

• Minimum Education BS in Human Factors Engineering, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field. MS strongly 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 medical device product development within a design controls process or healthcare setting (or similar highly regulated industry) is required.
• Demonstrated experience in HF (UX) and User Research project management
• Demonstrated experience of successful execution or direct support of regulatory submissions (Usability Engineering File) complete with Summative Usability Validation(s) per External Standards Guidance.
• 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. Mural or Batterii, Smarsheets etc)
• Demonstrated ability to advocate and effectively champion user-centered design and usability engineering principles to product research, development, and design in a fast-paced product development environment.
• Demonstrated ability to collaborate with and across various functional leadership 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 20%; 25-30%) 1 week a quarter: local hospital or customers in other parts of the country.