Senior Human Factors Engineer, Medical Device

The Opportunity

Quidel Ortho 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. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

At Quidel Ortho, we’re advancing the power of diagnostics for a healthier future for all
. Join our mission as our next Senior Human Factors Engineer to R&D new product platform and existing project workloads. This is an individual contributor role with, designing usability studies, performing usability assessments to inform design, providing inputs to product design, documenting the outcome of usability studies, and contributing to the human factors validation of medical diagnostic devices and products.

This individual will have opportunities for leading moderate-to-high complexity human factors projects, mentoring more junior staff, and providing input to the human factors process. Additionally, as time permits, the individual may contribute to systems engineering activities and deliverables.

This position will work onsite in Rochester, NY.

Note: 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.
• Design and execute formative and summative studies including working with project teams and external vendors participants and contracts, 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. This will be an intermittent activity; when user research is not needed this time will be reallocated to other engineering activities.
• Provide input on human factors process.
• Perform other work-related duties as assigned.

• Bachelor’s degree in biomedical or systems engineering or related field
• 5-7 years of biomedical or systems engineering experience, ideally with medical diagnostic equipment
• Experience working in a FDA / Regulated environment
• Strong written and verbal communication
independently
• Experience working with cross-functional development teams
• Demonstrated ability to lead moderate-to-large sized 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 regulatory standards and guidelines (e.g. 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

• Quality/Regulatory, Project Management, Systems Engineering, Product management, Lab Specialists, Software/ Hardware Engineering and other cross-functional members of the organization

• Clinical chemistry and transfusion medicine personnel (current and potential customers)
• Development partners

The work environment characteristics are representative of an office setting, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Intermittently time is spent in a manufacturing or laboratory environment and include potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples.

Occasional travel, domestically and…