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    Senior Human Factors Engineer - Cincinnati, United States - Kaleidoscope

    Kaleidoscope
    Kaleidoscope Cincinnati, United States

    1 week ago

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    Description
    JOB SUMMARY

    The Senior Human Factors Engineer (HFE) will independently manage early design research, and formative and summative research activities for external clients, and internal Kaleidoscope industrial designers, UX/UI designers for consumer, industrial and medical device products. This individual will be required to work a hybrid schedule.

    Working cross-functionally across the Kaleidoscope organization, the Senior HFE will lead human factors activities that include task analysis, use-related risk analysis, and formative and summative usability validation testing and reporting. The Senior Human Factors Engineer directly contributes to research efforts by leading, planning, authoring, and executing research, as well as analyzing the data and providing recommendations.

    The Senior HFE will demonstrate an in-depth knowledge of human factors design principles and usability testing methods, as well as an understanding of the product development process required for consumer and industrial products, as well as U.S. and EU health authorities' requirements for design controls for medical device development.

    PRINCIPAL DUTIES & RESPONSIBILITIES

    * Customer Development (20%)
    * With minimal supervision, manages customer expectations by delivering within expected budgets, timelines and project hours based on a project statements of work
    * Manages and executes HFE/UE scheduling to align with internal and customer expectations
    * Ensures on-time delivery, accurate and high quality HFE/UE project deliverables for self, as well as other HFE/UE colleagues
    * Keeps the Director of Human Factors and applicable leads apprised of any potential foreseen project constraints or issues pertaining to the on-time delivery and quality of project deliverables
    * Identifies customer needs and proposes innovative solutions
    * Assists in fostering positive business relationships with new and existing customers within target organization by delivering on-time, accurate and high-quality work product
    * Research Responsibilities (50%)
    *
  • a. Primary Research

    * Leads the development of usability plans and user needs specifications, task analyses, use related risk analyses, expert reviews, heuristic evaluations, and formative/summative validation studies
    * Designs and executes studies and reports observations and findings for usability studies at various stages of product development, from early prototypes through formative and summative studies
    * Collaborates in project core and brainstorming teams
    * Synthesizes and assembles relevant information into an appropriate format for the project (e.g., Word, Excel, PowerPoint)
    *
  • b. Secondary Research

    * Conducts secondary research to become knowledgeable about relevant category, product, or company to inform SOW development, project deliverables and project team efforts prior to project kickoff
    * Proactively searches for articles, studies, journals, etc. to assist with development of client deliverables
    * Development & Execution of Human Factors Program (20%)
    * Drives patient-focused product innovation by supporting the development of HFE processes within the organization
    * With minimal supervision, leads usability engineering activities associated within the development of medical devices and consumer products
    * Works closely with a cross-functional development team to ensure that user needs, usability requirements, and use errors are identified and addressed in the design process
    * Supports analytic human factors activities (e.g., use FMEA, task analysis, heuristic evaluation) for the purposes of design input, risk assessment and mitigation, and protocol development
    * Works closely with development engineers and R&D Management to ensure the HFE process is followed through all phases of the system lifecycle; advises development teams regarding compliance with IEC 62366, FDA Human Factors Engineering Guidance, and ANSI/AAMI HE75
    * Collaborates with internal human factors engineering stakeholders and across various levels within the organization
    * Quality / Continuous Improvement (10%)
    * Ensures company procedures are aligned with HFE standards and guidance documents
    * Ensure HFE procedures are aligned with local and global health authority standards and guidance documents
    * Delivers flawless deliverables to client
    * Manages deliverables and timing for self
    * Delivers research that meets Kaleidoscope's standards and when appropriate, international standards and regulations
    * Checks own work and that of peers, as requested
    * Mentors and collaborates with entry level staff
    * Participates in management of scope, schedule, and cost

    QUALIFICATIONS

    Education/Experience

    * Knowledge and skills at a level normally acquired through the completion of a Bachelor of Science (or higher) in Human Factors, Experimental Psychology, Cognitive Psychology, Cognitive Science, Industrial Design, Human-Computer Interaction, or related fields
    * 5-9+ years of professional experience, preferably in medical device development, or:

    * Knowledge and skills at a level normally acquired through the completion of a Master of Science (or higher) in Human Factors, Experimental Psychology, Cognitive Psychology, Cognitive Science, Industrial Design, Human-Computer Interaction, or related fields
    * 2-6+ years of professional experience, preferably in medical device development

    * Experience with all phases of the product development life cycle including feasibility, planning, requirements, design and development, verification and validation, design freeze and phase gates, and design transfer strongly preferred
    * Moderate understanding of FDA Quality System Regulation, ISO 13485, ISO 14971, and Medical Device Regulations (MDR) strongly preferred

    Licenses/Credentials/Certifications

    * N/A

    Skills/Specialized Knowledge/Abilities

    * Exhibits inward and outward executive presence for peers, colleagues, and clients relevant to a position of higher visibility
    * Exhibits excellent listening, analytical, negotiating and problem resolution skills appropriate to a senior position
    * Possesses good analytical and problem-solving skills
    * Synthesizes and drives towards appropriate solutions
    * Utilizes knowledge of research techniques including moderating and observing
    * Adequately uses Microsoft Office and Adobe applications: (Word, Excel, PowerPoint, Project, Outlook, Visio, Photoshop, Illustrator, InDesign, Acrobat)
    * Detail oriented work style and service
    * Works and thinks in a methodical and logical way
    * Prioritizes and completes tasks on time
    * Works collaboratively with colleagues and clients
    * Thinks for clarity, accuracy, precision, relevance, depth, breadth, significance, logic, and fairness
    * Writes and prepares documents/reports/proposals in a concise, logical, grammatically appropriate format
    * Takes direction from others and to accept constructive feedback while being adaptable and flexible
    * Communicates in a professional demeanor
    * Excellent listener
    * Manages sensitive information and maintain confidentiality
    * Stays focused and committed to a task

    WORKING CONDITIONS

    Tools and Equipment Used

    * Computer workstation, typical office equipment, Laboratory instrument and measurement equipment

    Travel

    * Light to moderate: 10%, up to 35% of the time

    Physical & Mental Demands

    * Frequently required to sit at a desk/workstation for an extended period of time
    * Digital dexterity and hand/eye coordination in operation of office equipment
    * Ability to effectively communicate to employees/clients via phone, computer or in person
    * Moderate lifting and carrying of supplies, equipment, files, etc.
    * Body motor skills sufficient to enable incumbent to move around the office environment
    * Ability to analyze unique situations and develop appropriate response

    Environment

    * Work typically performed in both an office and a laboratory setting

    Infosys is an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability.

    EEO/M/F/Disabity/Vet
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