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Anne E. is listed as Medical Device Human Factors Engineer at Catholic Community Services, based in Salt Lake City, Utah, United States. AeroLeads shows a matched LinkedIn profile for Anne E..
Anne E. previously worked as Refugee Family Mentor at Catholic Community Services and Lead Human Factors Engineer at Kaleidoscope. Anne E. holds Ba And Bs, English And Political Science from University Of Utah.
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Experienced medical device Human Factors professional with broad experience including:• IEC 60601-1-3, IEC 62366, HE 74, HE 75, 21 CFR, ISO 14971, ISO 13485, FDA regulations, /EUMDR• Contextual inquiry, task analysis, workflow diagrams, and use cases• Interaction design, and iterative UI development • Risk analysis• uFMECA• User requirements specifications and traceability• Use Specifications• Low to mid-fidelity prototyping• Validation plans and protocols• Iterative Formative and final Summative testing• Test participant recruiting• Test facilitation, data collection, and reporting• Defect tracking and analysis• Domestic and international cross-functional team collaboration• Training and mentoring• Application and improvement of quality management systems• SOP and work instruction authoring• Product labeling• Technologies: DOORs, Axure, MS Word, PowerPoint, Excel, Project, Visio, ClearQuest, Access, MyWorkshop, and MasterControl document management systems• Product remediation• Six sigma green belt certified
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Seattle, WA, US
Provide cultural orientation, job coaching and placement, provide transportation, teach English as second language, and orient clients on US healthcare system and use of public transportation. Provide opportunities for community integration and education for youth.
Minneapolis, Minnesota, US
Managed early-in-career team of Human Factors engineers in the application of compliant Human Factors methodologies for QudelOrtho immunohematology products. Revamped Human Factors process to bring into compliance with FDA and international standards.
Columbus, Ohio, US
Principal investigator for combination devices. Prepared IRB submissions and facilitated summative test sessions.
Marlborough, MA, US
Authored and executed formative study for pressure monitoring system. Provided human factors input to UFMEA.
Boston, MA, US
End user requirements gathering through use of standard human factors and usability methodologies. Positions held also included Six Sigma black belt and applications engineer.
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Anne E. works for Catholic Community Services.
Anne E. is listed as Medical Device Human Factors Engineer at Catholic Community Services.
Anne E. is based in Salt Lake City, Utah, United States while working with Catholic Community Services.
Anne E. has worked for Catholic Community Services, Kaleidoscope, Battelle, Boston Scientific, and Pfizer.
You can use AeroLeads to view verified contact signals for Anne E. at Catholic Community Services, including work email, phone, and LinkedIn data when available.
Anne E. holds Ba And Bs, English And Political Science from University Of Utah.
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