Senior Human Factors Engineer, Medical Device

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

At QuidelOrtho, 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 opportunities for evaluating use-related risk, 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.

The Responsibilities

• 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 to aid in coordination of participants and contracts, 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, 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.

The Individual

Required:

• 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
• Ability to work 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

Preferred:

• 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

The Key Working Relationships

Internal Partners:

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

External Partners:

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

The Work Environment

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 internationally. Flexible work hours to meet project deadlines

Physical Demands

No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation.

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 $100,000 to $125,000 and is bonus eligible. 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 recruiting@quidelortho.com.

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