Senior Human Factors Engineer - Cincinnati, United States - Kaleidoscope

Description

Job Description

Job 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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