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QuidelOrtho
Senior Human Factors Engineer
Career Insights for Process Engineer (General)
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Based on California data
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What they do
A Process Engineer solves problems related to the manufacturing and use of products, including chemicals, fuel, food, and clothing. Designs new products, improves existing ones, or develops new processes for better use of existing materials. May specialize in a chemical engineering process, such as making plastics, or in an industry such as health care.
$130,354 / year median in California
+10% projected growth
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.
- 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.
- 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.