Meredith Frazer
Principal Human Factors Engineer @Stryker
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WORK HISTORY
Principal Human Factors Engineer @Stryker
Weston, FL, US
Plan and conducted summative and formative usability testing of medical devices, including test protocol development, recruitment and logistics management, test session moderation, and reporting.• Create human factors engineering (HFE) documentation, including user needs, user interface evaluation plan, use specifications, task and risk analyses, formative/summative protocols/reports and the HFE report.• Collaborates cross-functionally with designers, product managers, engineers, and clinical experts in an agile development environment to plan and execute research activities.
EDUCATION
Georgia Institute of Technology
Polymer and Fiber Engineering, Polymers
ABOUT MEREDITH FRAZER
ASQ Certified Quality Engineer (CQE), Auditor (CQA), and Six Sigma Green Belt• 20 years experience in technological research and product development in a FDA regulated environment • 11+ year experience in project management • Detail-driven multi-tasker with excellent verbal, written, and analytical skills• Results-oriented well-focused team player• Proficient with the ability to learn and be trained rapidly• Efficient organizational and task management skills meeting specified time lines and company goals• Expert in Equipment, Software, Process and Sterilization Validations as well as Dose Audits• Expert in: Word, Excel, Power Point, Outlook, Visio, Photoshop, Microsoft Project, Internet Research, Adobe Acrobat Professional, Jama, onePLM, InDesign, QPulse, Blue HillSpecialties: • IEC 62366/FDA HFE Guidance/HE 75 • Product/System Risk Analysis (including Use)• Task Analysis• Simulated Use Testing• Patient/User Harms• Test Method Development• Structured and Semi-Structured Interviews• System Engineering• Requirement Development• Product/Use Risk Reduction • ISO 13485, 9001 and CFR 820 Quality System Regulations• Presentations, Technical Writing, Problem Solving and Data Analysis• Product/Process Design Project Management• Design and Process Failure Mode and Effect Analysis• Auditing to ISO 13485, ISO 9001, and 21 CFR 820, CQA• Process Validations (IQ/OQ/PQ) and Software Validations• Sterilization Validations and Dose Audits (ISO ISO 17665)
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