srch 11097: Director of Research and Usability

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Director of Research and Usability
Southern California
Search # 11097

Our client is a leading product development firm at the center of the booming medical industry. They are looking for a visionary with the passion and skills to develop their business even further. The ideal candidate must be a creative and analytical design who has a keen understanding of design implementation. They are comfortable not only with developing designs together with their colleagues, but also taking initiative in their projects. Most of all, they are dedicated to ensuring current and future success of the firm by strategically ensuring that the products and their usability are well researched.

Principal Responsibilities

  • Design, execute, and report on usability (human factors) research at various stages of product development, from early prototypes to validation testing required by FDA.

  • Moderate usability research sessions to gather key insights on potential use events that occur.

  • Translate uFMEA, risk/hazard analysis, and/or IFU into an appropriate usability testing protocol

  • Assist in defining user needs, translation of needs into measurable specifications, and the heuristic review of device-user interfaces.

  • Write and execute generative and evaluative research protocols, analyze research insights and data, and write test reports.

  • Provide input on FDA and Global usability regulatory standards (IEC 62366-1:2015, ANSI/AAMI HE75, EU MDR), FDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices.

  • Build human factors and usability research proposals and budgets.

  • Work with the Principals and other Directors on improving departmental processes around human factors and usability research.

  • Manage Usability Lab, including Host and Second Observer/Technician.




Experience Requirements

  • 7+ years of hands-on, professional applied human factors research experience within medical/healthcare industry, with expertise of IEC 62366-1 and FDA guidelines in this area.

  • A proven track record of delivering regulatory compliant validation research and providing guidance leading to the successful launch of physical products.

  • Demonstrable high standards of workmanship and attention to detail and ability to improve departmental processes and best practices.

  • Extensive experience conducting formative and summative validation studies

  • Ability to develop, support, and defend design recommendations based on experience with design research, ergonomics, and human factors principles

  • A deep familiarity with all forms of evaluative product research and ability to confidently guide a client in defining the user groups, intended uses, and use environments of the product

  • Ability to write effective proposals, plans, technical reports, and publications

  • Strong empathy and exceptional verbal communication skills to communicate with anyone, and unlock what users are thinking and feeling about a product.



Additional Training, Skills, Knowledge, and/or Experience

  • Specific skills in Cognitive Psychology (Masters or PhD) 

  • Specific training courses in Human Factors

  • General experience in Formative and Summative Testing using FDA Guidelines

  • Experience in the following areas

    • Competitive product and environment benchmarking and analysis

    • Surveys for user group studies and web-based research

    • Ethnography and Cognitive analysis

    • Workflow and Task analysis

    • Development of Personas, Storyboards, and Use-cases

    • Human Factors and Heuristic reviews

    • Safety and issue analysis

    • Usability testing and validation 

    • Practical use of testing software and video recording instruments

Due to the volume of applicants, we are unable to respond to each candidate. Please no phone calls.