Senior Human Factors Engineering Lead – Medical Devices

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 186,000 - 267,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking a Human Factors Manager to lead a team focused on usability engineering within a regulated design controls framework.

You will advocate for the clinical caregiver experience and ensure usability research informs product development across multiple projects. You will partner with engineering, regulatory, and clinical teams to drive usability evaluations, compile documentation for regulatory submissions, and oversee global usability programs, including

Qualifications

• Bachelor’s degree in engineering or related field; MS strongly preferred.
• 5+ years of related team management experience with a Bachelor's degree (in engineering); or 3 years and a Master's degree; or a relevant PhD with 4 years experience; or equivalent experience with human factors/biomedical devices.
• 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 global regulatory submissions.
• Keep abreast of regulations and best practices for medical device human factors and advise management regarding potential improvements to internal processes and regulatory issues related to usability engineering.
• Excellent verbal communication and presentation skills in a highly regulated environment.
• Experience with digital project collaboration tools (e.g. Mural, Smartsheets).
• Demonstrated ability to advocate and champion user-centered design and usability engineering in fast-paced product development.
• Ability to collaborate across management levels and travel internationally/domestically up to 20–30%.

Responsibilities

• Lead HF team planning and advocacy within cross-functional teams.
• Support and guide usability engineering initiatives within a regulated design controls environment.
• Establish and support project-based usability research strategy.
• Forecast planning and budgeting for usability research and testing efforts.
• Mentor HF team members translating design insights into actionable requirements.
• Support usability research execution and report to leadership.
• Balance testing across multiple projects from early prototypes to validation testing.
• Advocate for clinical caregiver experience in safety and usability.

Skills

Human Factors

UX Research

Regulatory Submissions

Project Management

Communication

Travel

Education

Bachelor's degree in engineering or related field

MS strongly preferred

PhD with 4 years experience

Equivalent HF/biomedical devices experience

Tools

Mural

Smartsheets

Job description

Intuitive Surgical, Inc. is seeking a Human Factors Manager to lead a team focused on usability engineering within a regulated design controls framework.

You will advocate for the clinical caregiver experience and ensure usability research informs product development across multiple projects. You will partner with engineering, regulatory, and clinical teams to drive usability evaluations, compile documentation for regulatory submissions, and oversee global usability programs, including