Principal Human Factors Engineer

3 weeks ago

San Diego, California, United States Goddard Inc. Full time
About the Role

We are seeking a highly skilled Principal Human Factors Engineer to join our team at Goddard Inc. in Beverly, MA or San Diego, CA. As a key member of our product development team, you will be responsible for leading human factors and usability engineering activities for new product development programs and driving usability improvements for current products.

Key Responsibilities
  • Be the Voice of the Patient/Customer: Serve as a patient/customer advocate in helping Goddard realize its vision for delivering game-changing products that are safe & effective, easy to use, not prone to use error, and provide user satisfaction.
  • Lead product management and product engineering personnel in establishing ergonomic, human factors (HF), and usability-related requirements for new products and product line extensions.
  • Represent the human factors/usability engineering function on core teams for small to large sized projects.
  • Advocate the human-centered design approach end-to-end in product development.
  • Implement a variety of HFE research methods, such as task analysis, PCA, time/motion study, user preference studies, ethnographic research, heuristic analysis, root cause analysis, post-market data analysis and usability testing.
  • Analyze quantitative and qualitative data to inform design decisions and risk analyses and contribute to user interface designs by providing heuristic design guidance, ideas, and feedback to project teams.
  • Be flexible with a range of product interfaces from software GUIs, hardware/fluid connectors to workstations, and inform/support creation of necessary prototypes for testing these with users.
  • Collaborate with internal & external parties in planning, structuring, recruiting for, and executing formative and summative usability evaluations (human factors validation studies).
  • Create and leverage uFMEAs or URRAs to inform design; collaborating with systems engineering in identifying intended users and use environments, as well as potential use-related hazards; determine product use cases and identify critical user tasks, errors, and design mitigations.
  • Adhere to latest regulatory standards and industry best practices.
  • Support documentation review and development, including but not limited to risk analyses, user/environment profiles, task analyses, use specifications and human factors engineering reports to support regulatory filings.
  • Have a thorough knowledge of the implementation of all relevant HF & usability-related standards and guidance documents (ANSI/AAMI/ISO 14971, AAMI/ANSI HE75, ANSI/AAMI/IEC 62366, IEC 60601, FDA, etc.).
  • Respond to regulatory inquiries from agencies and provide evidence of adherence, and rationale for human factors and usability engineering strategies adopted on a project.
  • Demonstrate leadership skills.
  • Strive to balance strategic planning and tactical execution.
  • Lead, guide, and mentor team members on day-to-day execution of activities.
  • Facilitate conflict resolution among resources and between clients and engineering teams.
  • Track and communicate progress of certain projects, paying particular attention to any developing problems, and participate in major problem resolutions.
  • Keep all privileged information private and confidential.
  • Travel as-needed (valid driver's license and vehicle required).

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