Manager, Human Factors

Intuitive; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive is seeking a Human Factors Manager to lead usability research strategy and mentor the HF team in translating insights into actionable requirements. You will collaborate with design engineering, product, and regulatory partners to ensure usability goals are met across development stages.

This role emphasizes patient-first care and safety in a regulated environment. The manager will steer cross-functional initiatives, prepare design controls documentation, and support regulatory

Qualifications

• Lead usability research strategy across projects in a regulated design controls environment.
• Mentor HF team members to translate design insights into actionable usability requirements.
• Coordinate with clinical engineering, software, product and program management teams.

Responsibilities

• Establish and support usability research strategy aligned with HF group initiatives.
• Forecast planning and budgeting for usability research and testing resources.
• Mentor HF team members to translate insights into usable requirements for devices.
• Execute usability research across stages from prototypes to regulatory validation testing in US/OUS markets.
• Advocate for patient-first caregiver experiences balancing user needs with business goals.

Skills

Leadership

Mentorship

Usability research

Cross-functional collaboration

Regulatory knowledge

Tools

Design controls

Job description

Job Description

Primary Function of Position:
The Human Factors Manager works closely with fellow Human Factors managers and engineers and collaborates with other cross‑functional managers of clinical engineering, system and software engineering, product managers, and program managers among other important functional teams in the development of novel technologies and devices. The Human Factors Manager primary role is to support, inform and guide development of Human Factors team members and represent the Human Factors function within and across business units, ensuring the successful execution of Human Factors Usability Engineering Initiatives, process activities and deliverables, while keeping a patient‑first mindset, acting as an advocate for the clinical caregiver end‑users regarding safety and usability, and as representative for medical device regulatory compliance.

As member of new 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, within a regulated design controls environment.

Roles and Responsibilities:

• Establish and support project‑based strategy for usability research, consistent with research strategy and initiatives across the Human Factors group.
• Forecast planning and budgeting for needed usability research and testing efforts, including estimates for needed resources and equipment.
• Mentor, support and guide HF team members in the translation of design insights into actionable usability considerations and requirements and proactively collaborate with design engineering partners to ensure best in class usability.
• Support the execution of, and report to leadership on, usability research and evaluations at various stages of product development. The Human Factors Manger will balance testing efforts across multiple projects from early prototypes to formal External Standards‑mandated validation testing in US and OUS market environments.
• 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.

• 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 formative study and user research activities.

• Write and revise highly accurate, clear, and concise usability engineering documents in a timely manner for multiple projects. 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.