Human Factors Manager

Intuitive•Sunnyvale, CA

19h

About The 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'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 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

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.
Excellent verbal communication and presentation skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms)
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.

Nice To Haves

Experience working with Digital project collaboration tools is appreciated. (e.g. Mural or Batterii, Smartsheets etc)

Responsibilities

Support, inform and guide development of Human Factors team members.
Represent the Human Factors function within and across business units.
Ensure successful execution of Human Factors Usability Engineering Initiatives, process activities and deliverables.
Act as an advocate for the clinical caregiver end-users regarding safety and usability.
Act as representative for medical device regulatory compliance.
Lead 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.
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.
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.
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.