Staff Engineer, Human Factors, Product Development

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Position Overview

The Staff Engineer Human Factors Product Development is a key problem solver and core team leader involved in cross-functional product development projects for In Vitro Diagnostics (IVD) medical devices from product concept to launch. This position will use expert technical skills to conceive plan and lead R&D product development usability activities to achieve project goals. This position will leverage understanding of usability engineering and human factors engineering methods and principles to influence the course of product development activities. The candidate shall have extensive knowledge about human behavior abilities limitations and other characteristics to apply to the design of medical devices.

Essential Duties

Include but are not limited to the following:

• 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 companys 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.

Minimum Qualifications

• Bachelors 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.

Preferred Qualifications

• Bachelors 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.

Salary Range:

National Range: $109000 - $185000

California Range: $135240 - $202860

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation holidays volunteering and personal time) paid leave for parents and caregivers a retirement savings plan wellness support and health benefits including medical prescription drug dental and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability protected veteran status and any other status protected by applicable local state or federal law.

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