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Principal Human Factors Engineer

Abbott · Milpitas +1 more

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Medical DeviceFull-time$131k–$261kCompany career page

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Role summary

Abbott seeks a Principal Human Factors Engineer to lead human-centered design strategy across physician-facing medical devices and patient-facing consumer health solutions. The role combines clinical safety, usability research, and regulatory expertise to optimize experiences across the product lifecycle from concept through commercialization.

What they're looking for

  • Bachelor's or Master's degree in Human Factors, HCI, Biomedical Engineering, Psychology, or related field
  • 8+ years human factors or usability engineering in regulated medical device or digital health environments
  • Deep knowledge of FDA Human Factors Guidance, IEC 62366, ISO 14971, and AAMI HE75 standards
  • Proven ability to conduct user research with healthcare professionals and patients using mixed-method approaches
  • Demonstrated experience influencing product strategy and executive decision-making as a principal contributor
  • Strong skills in usability validation, risk analysis, and regulatory documentation preparation
  • Excellent communication and presentation skills for cross-functional team engagement

What you'll be doing

  • Define and execute human factors vision and strategy across physician and patient-facing medical technologies
  • Lead usability engineering activities, use-related risk analyses, and regulatory submissions per FDA and international standards
  • Design and conduct formative and summative usability studies with physicians, patients, and consumers across diverse health literacy levels
  • Model and optimize end-to-end clinical and home environment workflows to reduce cognitive load and safety risks
  • Mentor design, engineering, and research teams on human-centered design principles and regulatory compliance expectations

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