What if the work you did every day could impact the lives of people you know? Or all of humanity?

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.

Position Summary:

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.

All About You

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.

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

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

The estimated base salary range for the Human Factors Engineer role based in the United States of America is: $98, 400 - $147, 600. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual's qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. 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 are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https: //www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.