Senior Human Factors Engineer

Ortho Clinical Diagnostics; San Diego (CA); On-site; USD 125,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan

Paid time off and holidays

Job summary

Ortho Clinical Diagnostics in San Diego is seeking a Senior Human Factors Engineer to evaluate use-related risks and design usability studies for medical diagnostic devices. The role involves collaborating with cross-functional teams and conducting formative and summative evaluations.

The ideal candidate will possess a Bachelor’s in biomedical or systems engineering and 5–7 years of relevant experience. The position offers a salary range of $125,000 to $150,000, including various benefits.

Qualifications

• 5–7 years of biomedical or systems engineering experience, ideally with medical diagnostic equipment.
• Experience leading moderate-to-large human factors projects.
• Strong written and verbal communication skills.

Responsibilities

• Design and document human factors engineering activities and usability studies.
• Support development of user interfaces through design and testing.
• Conduct early-stage user research via interviews and site visits.

Skills

Biomedical engineering

Systems engineering

User-centered design

Project management

Communication skills

Education

Bachelor’s degree in biomedical or systems engineering

Job description

Overview

At QuidelOrtho, we are looking for a Senior Human Factors Engineer to support our Point-Of-Care business. The role will involve evaluating use‑related risk, designing usability studies, performing assessments, and contributing to the validation of medical diagnostic devices.

Responsibilities

• Design, perform, and document human factors engineering activities: use specification, user needs, task analysis, use‑related risk analysis, formative and summative plans, protocols and reports, expert reviews, and summary reports for regulatory filing.
• Design and execute formative and summative studies, coordinating participants, contracts, site locations, equipment, and supplies with project teams and external vendors.
• 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: product requirement authoring, test protocol design and execution, and data analysis.
• Conduct early‑stage user research through interviews, site visits, and contextual inquiries; reallocate time to other engineering activities when research is not required.
• Provide input on the human factors process and perform other work‑related duties as assigned.
• Travel up to 25% domestically and internationally and work onsite at the San Diego, CA office.
• This position is not currently eligible for visa sponsorship.

Required 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 skills.
• Ability to work independently and with cross‑functional development teams.
• Demonstrated experience leading moderate‑to‑large human factors projects.
• Experience with 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 and user‑centered design methodologies.

Preferred Skills

• Prior experience with GUI workflow design.
• Experience with CLIA waived and near‑patient (POCT) use environment.
• Familiarity with regulatory standards (FDA Human Factors Guidance, IEC 62366, AAMI HE75, NMPA).
• Experience with customer‑facing activities, in‑vitro diagnostics products, and point‑of‑care test equipment.

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.

Work Environment

The role is performed in a manufacturing, laboratory, or warehouse environment that includes handling of viral and bacterial hazards, hazardous chemicals, and potentially infectious bodily fluids, tissues, and samples. Work requires up to 75% time at a desk, standing or sitting, and frequent travel. Physical demands are light, with occasional lifting of materials.

Salary and Benefits

Salary: $125,000 to $150,000, bonus eligible.

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

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including those with disabilities, have an opportunity to apply for positions 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. We provide reasonable accommodations to qualified individuals. If you require assistance to apply due to a disability, please contact [e-mail].