Exact Sciences

Staff Engineer, Human Factors – Product Development

Exact Sciences

full-time

Posted on:

Location Type: Hybrid

Location: Madison • Wisconsin • United States

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Salary

💰 $110,000 - $185,000 per year

Job Level

Lead

About the role

  • Leads planning, execution, and documentation of human factors engineering (HFE) and usability studies for IVD medical devices, ensuring compliance with IED 62366 and FDA human factors guidance.
  • Conducts formative and summative usability testing, user research, and cognitive task analysis to assess user-device interaction, identify use errors, and inform design improvements.
  • Manages usability and human factors requirements, including creation, decomposition, traceability, and validation of requirements derived from user needs and voice of customer.
  • Leads use-related risk management activities, including Use Failure Modes and Effects Analysis (uFMEA), Hazard Analysis related to use errors, and risk mitigation strategies.
  • Ensures comprehensive HFE documentation in Design History File (DHF); collaborates with Quality and Regulatory teams to support premarket submissions and compliance with usability engineering standards.
  • Drives cross-functional collaboration with hardware, software, reagent, manufacturing, and quality teams, providing HFE expertise, technical leadership, and influence on product design and user experience.
  • Upholds company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Supports and complies with the company’s Quality Management System policies and procedures.
  • Maintains regular and reliable attendance.
  • Ability to act with an inclusion mindset and model these behaviors for the organization.
  • Ability to work nights and/or weekends, as needed.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
  • Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
  • Ability to comply with any applicable personal protective equipment requirements.
  • Ability and means to travel 5% between Exact Sciences locations.
  • Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Requirements

  • Bachelor's degree in a field related to the essential duties
  • 8+ years of relevant experience in human factors engineering, usability engineering, or product development for medical devices, IVD diagnostics, biotechnology, pharmaceutical, or regulated clinical environments
  • Demonstrated experience leading usability studies, user research, and compliance activities for complex medical devices or user-facing regulated systems
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Benefits
  • paid time off (including days for vacation, holidays, volunteering, and personal time)
  • paid leave for parents and caregivers
  • retirement savings plan
  • wellness support
  • health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
human factors engineeringusability studiesformative usability testingsummative usability testingcognitive task analysisUse Failure Modes and Effects Analysis (uFMEA)Hazard Analysisrisk mitigation strategiesDesign History File (DHF)usability engineering standards
Soft Skills
cross-functional collaborationtechnical leadershipaccountabilityinnovationintegrityqualityteamworkinclusion mindset