Human Factors Engineer II

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry, and transfusion medicine. With over 6,000 employees and operations in more than 130 countries, we deliver fast, accurate, and consistent testing from home to hospital, lab to clinic. Our culture prioritizes employee happiness, inspiration, and engagement, fostering meaningful connections to drive both personal fulfillment and business success.

About the role

As a Senior Human Factors Engineer at QuidelOrtho, you will contribute to advancing the power of diagnostics for a healthier future. This individual contributor role focuses on evaluating use-related risk, designing usability studies, performing usability assessments, and informing product design. You will lead moderate-to-high complexity human factors projects, mentor junior staff, and provide input to the human factors process. Additionally, you may contribute to systems engineering activities. This position is based onsite in Rochester, NY and is not eligible for visa sponsorship.

Responsibilities

• Design, perform, and document human factors engineering activities, including use specification, user needs, task analysis, use-related risk analysis, formative and summative plans, protocols and reports, expert reviews, and human factors engineering summary reports for regulatory filings.
• Execute formative and summative studies, coordinating participants, contracts, study site locations, equipment, and supply needs with project teams and external vendors.
• Support the development of user interfaces through wireframing, 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.
• Conduct early-stage user research, including user interviews, site visits, and contextual inquiries, reallocating time to other engineering activities when user research is not needed.
• Provide input on the human factors process.
• Perform other work-related duties as assigned.

Requirements

• Bachelor’s degree in biomedical or systems engineering or a 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 and lead moderate-to-large human factors projects.
• Demonstrated experience in creation, execution, and documentation of human factors usability evaluations, formative and summative studies.
• Excellent attention to detail and 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).
• Ability to travel domestically and internationally, up to 25%.

Preferred Qualifications

• Experience working with Figma or a similar tool.
• Familiarity with human factors engineering of medical devices in compliance with regulatory standards (e.g., FDA Human Factors Guidance, IEC 62366, AAMI HE75).
• Familiarity 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.

Work Environment

The role operates primarily in an office setting, with occasional light lifting of files and related materials. Approximately 30% of time is spent in meetings, working with teams, or on calls, while 70% is spent at a desk on analytical work. Intermittent time may be spent in manufacturing or laboratory environments, which may involve exposure to hazardous chemicals, infectious bodily fluids, tissues, and samples. Occasional domestic and international travel is required, with flexible work hours to meet project deadlines.

Pay

The salary range for this position is $100,000 to $125,000, with bonus eligibility. Compensation decisions are based on factors such as education, experience, knowledge, skills, geography, and internal equity.

Benefits

• Comprehensive medical, dental, and vision insurance.
• Life and disability insurance.
• 401(k) plan.
• Employee assistance program.
• Employee Stock Purchase Plan.
• Paid time off, including sick time.
• Paid holidays.