Manager, Human Factors Engineering
About The Position
The Human Factors Manager works with other Human Factors managers and engineers and cross-functional partners, including clinical engineering, system and software engineering, product management, and program management, to develop novel technologies and devices. The role supports and develops Human Factors team members, represents the function across business units, and ensures successful execution of usability engineering initiatives, processes, and deliverables. The manager champions patient and clinical caregiver safety and usability, and represents medical-device regulatory compliance. As a key stakeholder on new product-development teams, the manager leads the Human Factors team’s planning, communication, and execution of appropriately scaled usability engineering activities before product launch in a regulated design-controls environment. The role establishes project strategies for usability research, forecasts research and testing resources and budgets, mentors team members, and supports and reports on research and evaluations throughout product development. Testing spans multiple projects, from early prototypes to formal validation testing required by external standards in U.S. and international markets. The manager advocates for the clinical caregiver experience while balancing user, customer, and business needs. The role engages professionally with end users in international markets during workflow-oriented formative studies and research; produces clear, accurate usability-engineering documentation and presentations; and prepares and reviews regulatory submission documentation, including responses to requests for further justification and rationale.
Requirements
- Bachelor’s degree in Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, Computer Science with an HCI emphasis, Human-Centered Design, or a related field.
- At least 5 years of related team-management experience with a bachelor’s degree in engineering; or 3 years with a master’s degree; or a relevant Ph.D. with 4 years of experience; or equivalent experience in human factors or biomedical devices.
- Experience in medical-device product development within a design-controls process, a healthcare setting, or a similar highly regulated industry.
- Demonstrated experience managing Human Factors (UX) and user-research projects.
- Demonstrated experience executing or directly supporting global regulatory submissions.
- Excellent verbal communication and presentation skills in a highly structured communication environment using channels such as email, text, video conference, and instant messaging.
- Ability to advocate for and champion user-centered design and usability-engineering principles in a fast-paced product-development environment.
- Ability to collaborate across functional teams and management levels, including engineering, marketing, clinical engineering, and regulatory, to resolve complex usability issues involving detailed risk analysis.
- Ability to travel domestically and internationally; the posting states travel may be up to 20% and also lists 25–30%.
Nice To Haves
- Master’s degree.
- Experience with digital project collaboration tools such as Mural or Smartsheets.
Responsibilities
- Support, develop, and guide Human Factors team members, and represent the Human Factors function within and across business units.
- Ensure successful execution of Human Factors usability-engineering initiatives, processes, and deliverables.
- Lead Human Factors planning, communication, and usability-engineering activities on new product-development teams within a regulated design-controls environment.
- Establish project-based usability research strategies that align with Human Factors group research strategy and initiatives.
- Forecast and budget for usability research and testing, including required resources and equipment.
- Mentor team members in translating design insights into actionable usability considerations and requirements, and collaborate with design engineering partners on usability.
- Support usability research and evaluations throughout product development and report results to leadership.
- Balance testing across multiple projects, from early prototypes through formal validation testing required by external standards in U.S. and international markets.
- Advocate for clinical caregiver safety and usability while balancing user, customer, and business needs.
- Work with end-user customers in international markets to gather design insights during formative usability studies and user research.
- Write and revise clear, accurate, and concise usability-engineering documents for multiple projects.
- Synthesize complex information into communications and presentations for product teams and organizational leadership.
- Prepare and review documentation for regulatory-agency and notified-body submissions, and support responses to requests for additional justification and rationale.
- Keep abreast of medical-device human-factors regulations and best practices, and advise management on potential process improvements and regulatory issues related to usability engineering.
Benefits
- Market-competitive compensation package including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
