Human Factors Engineer

Illumina • San Diego, CA

9d

About The Position

Illumina is seeking a Human Factors Engineer to join our growing team of experience designers and researchers as we build best-in-class customer experiences across all Illumina hardware and software products. You must be skilled with human factors and ergonomics research, applied cognitive research and human-machine integration design. Successful candidates should have a foundation in designing medical device experiences and be familiar with appropriate standards including IEC 62366-1 and -2, ANSI/AAMI HE75 and FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices. Experience with international regulatory bodies including IVDD and EU IVDR 2017/746 is a plus. In this role you will be responsible for driving human factors across a wide range of projects and must be comfortable conducting human factors research to understand user needs and use-related risk analysis to inform the design of research and clinical products. Supporting usability risk analyses, coordinating with technical writing as well as planning, conducting, analyzing and reporting on formative, summative usability studies and final human factors use validation and human factors task knowledge studies is an integral part of the work. Experience collaborating with regulatory groups to create human factors documentation required for medical devices and IVD submission to medical device regulatory agencies is a plus. You must be extremely organized, comfortable creating detailed documentation, and thrive in collaborating with others to drive towards success.

Requirements

• BS or MS Degree in Human Factors is required
• Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience; supporting hardware and software product development
• Demonstrated ability to support designs across product lines with ability to communicate with users, customers, engineering, product management, regulatory, clinical validation and compliance teams
• An understanding of the Product Development Life Cycle and experience in human factors and usability engineering, human-centered design and integration in regards to the requirements prescribed in ISO 9241-210 Human-Centered Design Process for Interactive Systems, ISO 62366-1:2015, 62366-2: 2016; FDA Guidance on Human Factors in medical devices (2016); and Content of Human Factors Information in Medical Device Marketing Submissions (2022); Medical Device Regulation EU IVDR 2017/746
• Experience with system level design, integration, and validation of usability requirements and hazard mitigation associated with product development with ability to gather and specify critical human factors system requirements, and clearly communicate design constraints and validation approaches internally and externally
• Experience in human factors/usability engineering for medical products, supporting the design and analysis of both human factors formative and summative usability studies including user research, focus groups, structured in-depth interviews, user needs and requirements analysis, use error analysis and use-related failure mode and effects analysis in defining critical tasks and human factors validation
• Ability to prioritize time between multiple projects and stay flexible with changing schedules and projects while working with multiple teams to deliver commitments on time

Nice To Haves

• Experience with international regulatory bodies including IVDD and EU IVDR 2017/746 is a plus.
• Experience collaborating with regulatory groups to create human factors documentation required for medical devices and IVD submission to medical device regulatory agencies is a plus.

Responsibilities

• Support the definition and design human factors solutions for new product development projects from product conception through post-release
• Provide Human Factors support across the product lifecycle including customer and user needs identification, development of user and use environment profiles and use cases, end-to-end workflows diagrams, requirements specification, information architectures, design concepts (e.g. creation of story boards), usability testing, summative usability studies, use error analysis and risk assessment
• Support the creation and execution of human factors plans, usability evaluations, scenarios/use case validations, human factors validation studies to ensure products can be used safely and effectively, and other user-centered design research
• Analyze and synthesize data from user research and usability studies, and partner closely with design and product teams to synthesize findings into actionable design requirements and specification.
• Support the development and maintenance of human factors documents, requirements, and use-related risk assessment analyses
• Suggest design recommendations based on user needs and results from human factors formative and summative research across the product life cycle
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Benefits

• We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
• We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees