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 they9re essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together 6 Collaborate intentionally, grow as a team
• Make It Happen 6 Focus on priorities, embrace continuous improvement
• Commit to Service 6 Cultivate a service mindset
• Embrace Inclusion 6 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. 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.

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