Ryan Kimmel Email & Phone Number

Madison, Wisconsin, United States

-Lead supplier quality team responsible for managing >2500 active vendors that support electrical equipment, IVD, API, and research use only products.-Establish and maintain processes to comply with regulations and standards including 21 CFR, ISO 9001, ISO 13485, ISO 18385, IVDR, CE, and ICH Q7.-Strategic planning to set vision and mission statements, review SWOT, set strategic initiatives, and systematically score and prioritize projects to ensure effective and efficient deployment of resources.-Vendor lifecycle management, including qualification, audits, written agreements, acceptance testing of incoming materials, and performance monitoring-Quality assurance expert for instrument design, development, and manufacturing.

Madison, Wisconsin Area

-Experienced leader in Quality for instrument manufacturing operations-Team is responsible for key quality processes including QC, change management, nonconforming product, and supplier performance monitoring, including auditing-Led RoHS compliance initiative which included corporate policy, evaluation of existing products, redesign with compliant components, and inventory control-Led transition to ISO 13485:2016 -Led integration of quality management systems of a former manufacturing branch-Design team member for next generation instruments-QA technical lead for instrument performance investigations-Factory representative for instrument safety compliance

Madison, Wisconsin Area

Led cross-functional continuous improvement initiates, including ISO certifications, alignment to regulations for medical device manufacturers, and process developmentLed complaint investigation team for escalated global product issuesLed annual quality planning, including quality system data reviewsSME in statistical process controlSoftware development for various processes in operationsSME in human factors engineering for product development

Madison, Wisconsin

Accomplishments include:-Built a supplier quality program-Created a biomechanically efficient receiving area to enhance space utilization while reducing the potential for injuries-Designed equipment for controlled temperature kit packaging-Designed cryogenic laboratory and processes for bioassay kits for biologic drug development-Led cross-functional team to assess the current training program and identify continuous improvement objectives to ensure efficient and sustainable processes.-Led implementation of validated software modules for various business systems, including Complaint Investigation, Lab Investigation, Nonconformance, and Quarantine/Review/Disposition , with an estimated ROI of 77%-Led implementation of automated metrics reporting systems in Visual Studio and SAP BOBJ-Led cross-functional teams for product investigations including for Class 1 Medical Devices-Led multi-phase, cross-functional initiative to align business processes for compliance with 21CFR820, 803, 806, and 807; ISO 9001:2015; and ISO 13485:2016-Led strategy sessions to identify vision, mission, strategic pillars, and objectives for the Supplier Quality and Escalated Complaint Investigation networks in alignment with corporate and department goals-Designed a tool and policy for automated statistical sampling plans based on the ANSI Z1.4-2003 Sampling Standard for Quality Control.-Assessed complex changes to quality systems, products, and processes.

Des Plaines, Il

Jul 2013 - Dec 2014: Quality Engineer for Abbott Molecular, Global Supply Chain Quality-Des Plaines, ILJan 2013 - Jun 2013: R&D Engineer and R&D Manufacturing Line Supervisor for Abbott Vascular, Coronary Catheter R&D-Temecula, CAJul 2012 - Dec 2012: Purchasing Agent for Abbott Diagnostics Division, Global Purchasing Department-Lake Forest, ILJan - Jun 2012: Quality Engineer for Global Pharmaceuticals Research & Development Division, GMP Finishing QA-Abbott Park, IL

Wisconsin Institutes For Discovery, Madison, Wi

-Led research project in Cave Automatic Virtual Environment (CAVE)-Researched perception differences in real vs. virtual object proximities-First to use EMG signals for virtual object manipulaiton

Abbott Park, Il

-Designed and conducted usability studies of internal online tools-Performed biomechanical analysis of diagnostic kit packing facility-Supported usability studies of the Humira self-injectable pen

Madison, Wi

-Developed equipment for a 300% increase in production throughput of AssayMAP chromatography cartridges-Developed a microparticle metering system-Created solftware for measuring, organizing, and labeling solution vials

Madison, Wi

-Developed a resin concentration measurement system-Made improvements to the AssayMAP chromatography column packing process

Performed both independent and collaborative research that provided influence for new rehabilitation techniques for patients recovering from a stroke. Research included examining the magnitude and angle of the foot-force when the patient is positioned at different orientations with respect to gravity.

M.S., Biomedical Engineering

Focus on rehabilitation and human factors engineering

B.S., Biomedical Engineering - Biomechanics

Activities and Societies: Tau Beta Pi Engineering Honors Society, Tong Design Competition, Biomedical Engineering Society, UW.

B.S., Biomedical Engineering

Activities and Societies: DTU Cycling Club, International Food ClubForeign exchange student at DTU in biomedical engineering.