Human Factors Engineer II

The Role

Senior Human Factors Engineer – R&D new product platform and existing project workloads. This individual will evaluate use‑related risk, design usability studies, perform usability assessments, provide inputs to product design, document study outcomes, and contribute to the validation of medical diagnostic devices and products. Responsibilities include leading moderate‑to‑high complexity human factors projects, mentoring junior staff, and providing input to the human factors process.

The role is located onsite in Rochester, NY. This position is not currently eligible for visa sponsorship.

• Design, perform, and document human factors engineering activities in support of projects: use specification, user needs, task analysis, use‑related risk analysis, formative and summative plans, protocols and reports, expert reviews, and human factors engineering summary report, for inclusion in regulatory filing.
• Execute formative and summative studies, working with project teams to coordinate participants and contracts, study site location, equipment and supply needs, and supportive functional needs.
• Design and execute formative and summative studies with project teams and external vendors, assisting in participant and contract coordination, study site location, equipment, and supply needs.
• Support development of user interfaces, including wire framing, rapid prototyping, hardware touchpoints, and evaluation of complex interface workflows via direct usability testing.
• Contribute to systems engineering activities, including product requirement authoring and management, test protocol design and execution, and data analysis.
• Provide early‑stage development with user research by conducting user interviews, site visits, and contextual inquiries. When user research is not required, time will be reallocated to other engineering activities.
• Provide input on the human factors process.
• Perform other work‑related duties as assigned.

• Bachelor’s degree in biomedical, systems engineering, or related field.
• 3–5 years of biomedical or systems engineering experience, ideally with medical diagnostic equipment.
• Experience working in an FDA‑regulated environment.
• Strong written and verbal communication skills.
• Ability to work independently.
• Experience working with cross‑functional development teams.
• Demonstrated ability to lead moderate‑to‑large human factors projects and related activities.
• Demonstrated experience in creation, execution, and documentation of human factors usability evaluations, formative and summative studies.
• Excellent attention to detail.
• Ability to work effectively in a collaborative, cross‑functional team environment.
• Exposure to Human Factors concepts applying user‑centered design methodologies (e.g., user needs assessment, design concepts, and usability evaluations in support of product development).
• Ability to travel domestically and internationally, up to 25%.
• This position is not currently eligible for visa sponsorship.

• Experience working with Figma or a similar tool.
• Familiarity with Human Factors Engineering of medical devices in compliance with FDA Human Factors Guidance, IEC 62366, AAMI HE75.
• Familiarity with Human Factors Engineering of medical devices in compliance with international regulatory standards (e.g., NMPA).
• Experience in conducting customer‑facing activities.
• Experience with in vitro diagnostics products and diagnostic equipment for blood testing.

Internal Partners: Quality/Regulatory, Project Management, Systems Engineering, Product Management, Lab Specialists, Software/Hardware Engineering, and other cross‑functional members.

External Partners: Clinical chemistry and transfusion medicine personnel (current and potential customers), development partners.

The work environment is representative of an office setting, with occasional light lifting of files and related materials. Approximately 30% of time is spent in meetings or talking on the phone, and 70% at a desk on computer. Intermittently time is spent in a manufacturing or laboratory environment, which may involve potentially hazardous chemicals, infectious or…