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Primary Talent Partners · 1 day ago

Human Factors Design Engineer II

North Haven, CT

Contract

Onsite

Entry, Mid Level

$45/hr - $65/hr

2+ years exp

Primary Talent Partners has a new contract opening for a Human Factors Design Engineer II with their medical device client. The role involves leading human factors efforts within the User Centered Design functional group, focusing on usability studies, user research, and human factors engineering for product development.

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Responsibilities

Designing usability studies and driving testing strategies

Moderating usability testing of prototypes with end users and customers

Aiding in data collection and root cause analysis during usability testing

Responsible for Use-related Risk Analysis documentation

Provide technical insight for user interface design, HF processes, and planning for team and business strategy

Perform observation / contextual inquiry for applicable use cases/environments e.g. Surgery

Moderate interviews with end users and customers for the purpose of need finding, use case identification, use condition identification, use error identification, validation of customer and user needs, and determining effectiveness of risk controls

Contribute and maintain human factors program documentation as needed for the Usability Engineering File

Aiding teams with preparation of usability-related documentation for regulatory body submissions

Aid in identifying use-related issues upon post-market launch and provide recommendations of risk control enhancements

Applies human centered principles, methodologies, and technologies to the design of human-machine systems and products

Develops and implements research methodologies and both qualitative and quantitative analysis plans to test and evaluate new concepts and developmental prototypes used in all phases of products development and processes

Designs and executes tests to simulate product use for the purposes of user need investigation, concept exploration/selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces and overall user experience

Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans to inform the design direction of new product development

Qualification

Usability testingHuman factors program activitiesUse-related Risk analysisHuman-centered designMedical device experienceData collectionRoot cause analysisUser interface designRegulatory submissionsQualitative analysisQuantitative analysis

Required

BS in Human Factors or a closely-related field (such as Biomedical Engineering, Industrial Design, Industrial Engineering) with 2+ years' experience; MS or higher with 0 years' experience (specific experience in medical device development is strongly preferred)

Planning, conducting, and documenting usability testing in a medical device use context

Planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (e.g., IEC 62366, IEC 60601, ISO 14971)

Use-related Risk analysis