Manager, Human Factors Engineering

Intuitive•Sunnyvale, CA

About The Position

The Human Factors Manager collaborates with Human Factors colleagues and cross-functional leaders in clinical engineering, system and software engineering, product management, program management, and other teams to develop new technologies and devices. The role supports and guides Human Factors team members and represents the function across business units, ensuring execution of usability engineering initiatives, processes, and deliverables in a regulated design-controls environment. The manager advocates for clinical caregiver end-users, patient safety, usability, and medical-device regulatory compliance. As a key stakeholder on new product-development teams, the manager helps the Human Factors team plan and communicate its work, advocate for the value of the function, and carry out appropriately scaled usability engineering activities before launch. The role establishes project strategies for usability research, plans and budgets research and testing resources, mentors team members, supports research and evaluations, and reports results to leadership. Testing is balanced across multiple projects, from early prototypes through formal validation testing required by external standards in U.S. and other markets. The manager engages professionally with end-user customers in international markets to gather design insights through workflow-oriented formative studies and user research. The role produces clear, accurate usability engineering documents, synthesizes complex information for product teams and organizational leaders, and prepares and reviews regulatory submission documentation, including responses to requests for additional justification and rationale. Domestic and international travel is required, stated as up to 20%; 25–30%.

Requirements

Bachelor’s degree in Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, Computer Science with a human-computer interface emphasis, Human Centered Design, or a related field; a master’s degree is strongly preferred.
At least 5 years of related team management experience with a bachelor’s degree in engineering; or 3 years with a master’s degree; or a relevant PhD with 4 years of experience; or equivalent experience with human factors/biomedical devices.
Experience in medical-device product development within a design-controls process, healthcare setting, or similar highly regulated industry.
Demonstrated experience managing Human Factors (UX) and user research projects.
Demonstrated experience with successful execution of or direct support for global regulatory submissions.
Knowledge of medical-device human-factors regulations and practices, including IEC 62366, AAMI HE75, and FDA guidance on applying Human Factors and Usability Engineering to Medical Devices.
Excellent verbal communication and presentation skills in a highly structured communication environment using multiple channels.
Ability to advocate for and champion user-centered design and usability engineering principles in a fast-paced product-development environment.
Ability to collaborate across functional leadership and management levels, including engineering, marketing, clinical engineering, and regulatory teams, to resolve complex usability issues involving detailed risk analysis.
Ability to travel internationally and domestically; travel is stated as up to 20%; 25–30%.

Nice To Haves

Master’s degree in a relevant field is strongly preferred.
Experience with digital project collaboration tools such as Mural and Smartsheets.

Responsibilities

Collaborate with Human Factors colleagues and cross-functional managers and teams in the development of novel technologies and devices.
Support, inform, and guide Human Factors team members and represent the Human Factors function within and across business units.
Ensure successful execution of Human Factors usability engineering initiatives, process activities, and deliverables in a regulated design-controls environment.
Advocate for clinical caregiver end-users, safety, usability, and medical-device regulatory compliance.
Lead Human Factors as a key stakeholder on new product-development project teams, helping the team plan, communicate, and execute appropriately scaled usability engineering activities before product launch.
Establish project-based usability research strategies consistent with Human Factors group research strategy and initiatives.
Forecast and budget usability research and testing needs, including required resources and equipment.
Mentor and guide team members in translating design insights into actionable usability considerations and requirements, and collaborate with design engineering partners to support usability.
Support usability research and evaluations throughout product development and report results to leadership.
Balance testing across multiple projects, from early prototypes to formal validation testing required by external standards in U.S. and other market environments.
Advocate for clinical caregiver experience while balancing user/customer needs and business needs.
Interface with end-user customers in international markets to gather design insights through workflow-oriented formative studies and user research.
Write and revise accurate, clear, and concise usability engineering documents for multiple projects in a timely manner.
Synthesize complex information into internal communications and presentations for product teams and organizational leadership.
Prepare and review regulatory submission documentation and support responses to requests for additional justification and rationale.
Keep abreast of medical-device human-factors regulations and best practices and advise management on process improvements and regulatory issues related to usability engineering.
Travel domestically and internationally as required.