Human Factors Engineer

Position Summary:

Illumina is seeking aHuman Factors Engineer to join our growing team ofexperiencedesigners and researchers as we build best-in-class customer experiences across all Illumina hardware and softwareproducts. You must be skilled withhuman factors and ergonomics research applied cognitiveresearchand human-machine integration candidates should have a foundation in designing medical device experiences andbe familiar withappropriate standardsincluding IEC 62366-1 and -2 ANSI/AAMI HE75 and FDA guidance on Applying Human Factors and Usability Engineering to Medical with international regulatory bodies including IVDD and EU IVDR 2017/746is a plus.

In this role you willbe responsible fordriving human factors across a widerangeofprojects andmust be comfortable conducting human factors research to understand user needs and use-related riskanalysisto inform the design of research andclinicalproducts. Supporting usability risk analyses coordinating with technical writingas well as planning conductinganalyzingand reporting on formative summative usabilitystudiesand final human factorsusevalidationand human factors task knowledge studiesis an integral part of the work. Experience collaborating with regulatory groups to createhuman factorsdocumentationrequiredfor medical devicesand IVD submission to medical device regulatory agencies is a plus. You must be extremely organized comfortable creating detailed documentation andthrive incollaborating with others to drive towards success.

All About You

Responsibilities:

• Support the definitionand design human factors solutions for new product development projects from product conception through post-release

• Provide Human Factors support across the product lifecycle includingcustomer and user needs identification development of user anduse environmentprofiles and use cases end-to-end workflowsdiagrams requirements specification information architectures design concepts ( of story boards) usability testingsummative usability studiesuse error analysisand risk assessment

• Support the creationand execution ofhuman factors plansusability 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 designrequirementsandspecification.

• Support the developmentand maintenance ofhuman factorsdocuments requirements anduse-relatedrisk assessmentanalyses

• Suggestdesign recommendations based on userneedsand results fromhuman factorsformative and summative research across the product life cycle

All listed tasks and responsibilities aredeemed asessential functions to this position; however business conditions may require reasonable accommodations foradditionaltaskand responsibilities.

Requirements:

• BSorMS Degree in Human Factors isrequired

• Typically requires a Bachelors 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 lineswith ability to communicate with users customers engineering product management regulatory clinicalvalidationand complianceteams

• Anunderstanding 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 ISO9241-210Human-Centered Design Process for Interactive Systems ISO 62366-1:-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 RegulationEU IVDR 2017/746

• Experience with system level design integration and validation of usability requirements and hazardmitigationassociated with product development with ability to gather and specify critical human factors system requirements and clearly communicate design constraints andvalidation approaches internally and externally

• Experienceinhuman factors/usability engineering for medical productssupporting thedesignandanalysis ofbothhuman factorsformative and summativeusabilitystudies including user research focus groups structured in-depth interviews user needs and requirements analysis useerror 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.