Manager, Human Factors Engineering

Description

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's 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 a 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.

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

Requirements

• What You'll Bring
• Minimum Education: BS in Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field. MS strongly preferred.
• Minimum of 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 (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.
• 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, Smartsheets, 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%)
• Additional Information
• 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.
• Mandatory Notices
• U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.
• Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
• For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
• 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.
• This position may be filled at a different job level than listed here depending on
• business need and/or on the selected candidate’s experience, knowledge and skills.
• Compensation will be based primarily on the job level at which the role is filled and the
• candidate’s qualifications, consistent with applicable law.