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. 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.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Biomedical Engineer with exposure into human factors engineering practices. This person will be an individual contributor with opportunities on providing inputs to product design, evaluating use-related risk, performing usability assessments to inform design, and contributing to the Human Factors validation of In Vitro Diagnostics devices and products. This individual will have opportunities for mentoring more junior staff and support human factors process improvements.

This position will be working onsite full-time at our Rochester, NY location.

The Responsibilities

• Perform and document human factors engineering activities in support of projects: User needs, user specifications, task analysis, use-related risk analysis, formative and summative plans, protocols and reports, expert reviews and human factors engineering summary reports for inclusion in regulatory filing.
• Execute formative and summative studies including working with project to support recruitment of participants, study site location, equipment, and supply needs.
• Support development of user interfaces, including 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.
• Provide early-stage development with user research by conducting user interviews, site visits, contextual inquiries.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor's degree in biomedical or systems engineering with exposure/interest in human factors.
• 4-5 years of biomedical or systems engineering experience, ideally with medical diagnostic equipment.
• Strong written and verbal communication.
• Must be a self-starter and ability to work independently.
• Experience collaborating with multi-functional development teams.
• Prior human factors experience is not required.
• Ability to work efficiently within a defined process and make quality decisions.

Preferred:

• 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)
• 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).
• Experience in conducting customer-facing activities.
• Experience with in vitro diagnostics products and diagnostic equipment for blood testing.

The Key Working Relationships

Internal Partners:

• Quality/Regulatory, Project Management, System Engineering, Product management, Lab Specialists, and Software/ Hardware Engineer.

External Partners:

• Customers and development partners.

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $57,000 to $104,000. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at .

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