Associate Human Factors Engineer

Illumina•San Diego, CA

About The Position

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Illumina is seeking an Associate 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. 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 clincal products. Supporting usability risk analyses, coordinating with technical writing to deliver technical illustrations for user documentation as well as planning, conducting, analyzing and reporting on rapid iterative, formative, summative usability studies and final human factors use validation and human factors task knowledge studies is an integral part of the work. 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
1+ year with a bachelor’s degree or less time with a master’s degree 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
Ability to create 3D models from CAD to produce technical illustrations, sequences, animations.
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, usability testing, 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.
Create technical illustrations based on CAD and photo image assets to supplement user documentation.
Support the development and maintenance of human factors documents, requirements, and use-related risk assessment analyses