Job Summary

Company: Kaleidoscope Animations
Location: Cincinnati, OH
Industries: Advertising and PR Services
Job Type: Full Time; Employee
Job Reference Code: 1063

Senior Human Factors Engineer

About the Job

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.

Working cross-functionally across the Kaleidoscope organization, the Senior HFE will lead human factors activities that include activities planning, use-related risk management, design research, and formative and summative usability testing and reporting. The Senior Human Factors Engineer directly contributes to research efforts by participating on client core teams, leading, planning, authoring and executing research, and analyzing resultant data and recommendations leading to opportunities for product improvement, enhancement and innovation,

The Senior HFE will have demonstrated, and in-depth knowledge of human factors design principles and usability testing methods, as well as a keen 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

1. 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 coordinated HFE/UE scheduling and technical requirements with internal core teams, overall, I/HF project schedules 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 managers/leads apprised of any potential foreseen project constraints and/or issues pertaining the on-time delivery and/or 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

2. Research Responsibilities (50%)

a. Primary Research

Leads in developing the authoring of usability plans and user needs specifications, hazard analyses, task analyses, use error and risk analyses, expert reviews, heuristic evaluations and usability verification and validation for client products (as applicable)
Designs and executes studies and report observations and findings for usability studies at various stages of product development from early prototypes through formative and summative formal health authority-mandated requirements and guidance.
Leads observational, ethnographic, surveys, in-person and remote, as an example, research as needed to uncover unmet needs
Collaborates in project core and brainstorming teams
Manages client feedback process including analyzing, summarizing, and reporting data for the company
Synthesizes and assembles relevant information into an appropriate format for the project (e.g., 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

3. 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

4. Quality / Continuous Improvement (10%)

Ensures companys 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 Kaleidoscopes 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
1. At least 5 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
1. At least 2 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, Medical Device Regulations (MDR), and IEC 62304 requirements strongly preferred

Licenses/Credentials/Certifications

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
Displays proficiency in documentation, dimensioning and specification writing
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)
Detailed oriented work style and service
Works and thinks in a methodical and logical way
Prioritizes and completes tasks in order to deliver desired outcomes within allotted time frames
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
Handles 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 long 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

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

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