Senior Human Factors Engineer

RXinsider LTD.; San Diego, Northern (CA, KY); Hybrid; USD 125,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) plan

Employee assistance program

Employee Stock Purchase Plan

Paid time off

Job summary

QuidelOrtho is seeking a Senior Human Factors Engineer for our San Diego site to advance diagnostics for a healthier future. You will lead HF activities, perform usability studies, and contribute to regulatory filings while collaborating with product, quality, and systems engineering teams.

The role requires 5–7 years in HF with medical devices, strong communication, and the ability to work independently. Travel up to 25% domestically and internationally is expected.

Qualifications

• 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.
• Strong written and verbal communication.
• Ability to work independently.
• Experience working with cross-functional development teams.
• Demonstrated ability to lead moderate-to-large Human Factors projects.

Responsibilities

• Design, perform, and document HF activities including use-related risk analyses and usability reports for regulatory filing.
• Design and execute formative and summative studies with teams and vendors.
• Support development of user interfaces, wireframes, rapid prototyping, and evaluation of complex workflows.
• Contribute to systems engineering activities like requirement management and data analysis.
• Provide input on HF process and conduct user research when needed.
• Perform other duties as assigned.

Skills

Communication

Independent work

Cross-functional teams

Lead HF projects

HF evaluations

User-centered design

Regulatory awareness

Travel readiness

Regulatory standards

Education

Bachelor’s degree in biomedical or systems engineering

Job description

The Opportunity

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 support our Point-Of-Care business. The Senior Human Factors Engineer responsibilities will include 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 support prior human factors analysis, study design, and study execution experience is required; on-the-job-training will be performed as needed for knowledge of products and process. There will be opportunities for leading moderate-to-high complexity human factors projects and providing input to the human factors process.

This position will be onsite at our San Diego, CA (Summers Ridge – Sorrento Valley) office.

NOTE: this role will require travel up to 25% domestically and internationally.

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
• 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)

Preferred Skills

• Prior experience with GUI workflow design
• Experience with CLIA waived and near patient (POCT) use environment.
• 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 point of care test equipment
• This position is not currently eligible for visa sponsorship.

The Key Working Relationships

Internal Partners

• Quality/Regulatory
• Project Management
• Systems Engineering
• Product management
• Lab Specialists
• Software/ Hardware Engineering

External Partners

• Point of care medicine personnel (current and potential customers)
• Development partners

How We Work

At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they’re essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together – Collaborate intentionally, grow as a team
• Make It Happen – Focus on priorities, embrace continuous improvement
• Commit to Service – Cultivate a service mindset
• Embrace Inclusion – Be open and authentic, welcome diverse perspectives

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. Travel required. Travel includes airplane, automobile travel and overnight hotel.

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 $125,000 to $150,000 and is bonus eligible.

• medical
• dental
• vision
• life
• disability insurance
• 401(k) plan
• employee assistance program
• Employee Stock Purchase Plan
• paid time off (including sick time)
• 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 [e-mail].