Staff Engineer, Human Factors, Product Development

Exact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. The Staff Engineer, Human Factors, Product Development will lead cross-functional product development projects for In Vitro Diagnostics medical devices, focusing on usability engineering and human factors to ensure effective user-device interaction and compliance with regulatory standards.

Responsibilities:

• 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
• Bachelor's degree in Usability/Human Factors Engineering
• Advanced degree (Masters / PhD)
• Experience with international standard IEC 62366-1 (Application of usability engineering to medical devices)
• Experience with next generation sequencing, immuno-histochemistry, in-situ hybridization, PCR, methylation
• Experience with instrument automation or scientific instrumentation
• Experience with system analysis, model-based system engineering, and system architecture
• Design for Six Sigma (DFSS) experience
• Experience with formal Design Control processes
• Ability to conduct user testing, generate outcome reports, and communicate insights from testing outcomes to the core team and non-technical stakeholders
• Demonstrated ability to influence and shape the technical direction of projects and teams
• Experience building relationships across functional areas to utilize user ability methods and practices