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Human Factors Manager

External
Intuitive logoIntuitive · Sunnyvale, CA
Full-timeOn-site1d ago
BudgetingComplianceDocumentationLeadershipUser Research
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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

Requirements

  • 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.
  • 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 or Batterii, 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%) and comply with local and international hospital health and vaccination policies
  • 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.
  • Intuitive is an Equal Opp

Benefits

Health insurance

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