Job Description
Job Description
Job Description
JOB SUMMARY
The Human Factors Engineer will work independently to contribute to the human factors efforts for a broad range of usability studies for our med-tech clients. This individual will work on assigned projects to provide support for the Human Facts/Usability Engineering activities. This individual will conduct user research and user studies and will develop user needs and requirements documents.
PRINCIPAL DUTIES & RESPONSIBILITIES
1.
User Studies (60%)
- Responsible for: usability specifications, task analyses, usability risk analyses and UI evaluation plans for products
- Strategize, design and execute usability studies at various stages of product development form early prototypes through formative and summative evaluations at various stages of product development from early prototypes through formal FDA-mandated validation
- Participates in observational research as needed to uncover unmet needs
- Participates in project research and brainstorming teams
2.
Development & Execution of Human Factors Program (30%)
- Drive patient-focused product innovation by supporting the development of human factors engineering processes within the organization, including the management of standard operating procedures
- Lead usability engineering activities associated within the development of medical devices
- Works closely with a cross-functional development team to ensure that user needs, usability requirements, and user errors are identified and addressed in the design process
- Develops product documentation that supports high quality production
- Employs DFM, DFA and DFQ
- Uses advanced engineering modeling and simulation tools, instrumentation and measurement and design of experiments
- Support 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
- Work closely with development engineers and R&D Management to ensure the HF/UE process is followed through all phases of the system lifecycle; advise development teams regarding compliance with IEC 62366, FDA Human Factors Engineering Guidance, and HE75 guidance
- Collaborate with internal human factors engineering stakeholders and across various levels within the organization
3.
Quality / Continuous Improvement (10%)
- Ensure company’s procedures are aligned with human factors engineering 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, Industrial Engineering, Human-Computer Interaction or related fields
- 0-2+ years of professional experience in medical device development strongly preferred
- Experience with all phases of the product development life cycle including feasibility, planning, requirements, design and development, verification and validation and design transfer strongly preferred
- Moderate understanding of FDA Quality System Regulation, ISO 13485, ISO 14971, Medical Device Directives (MDD), IEC 62304 and IEC 62366 requirements strongly preferred
Licenses/Credentials/Certifications
Skills/Specialized Knowledge/Abilities
- 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 applications: (Word, Excel, PowerPoint, Project, Outlook, Visio)
- 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 25% 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
Job Tags
Flexible hours,