Molly Kimbley Email & Phone Number

Newport Beach, California, United States

Laguna Hills, California, United States

• Owned transfer of chemical processes from experimental phase to scalable manufacturing for novel continuous glucose monitoring technology• Established and implemented documentation to drive quality within startup environment (work instructions, QCPs, MFG routers, IQs, etc.)• Designed and executed R&D experiments (DOE) and managed manufacturing builds• Quantified process performance through variable/attribute data collection and analysis, and conducted root cause investigations• Procured, installed, qualified, and troubleshooted equipment• Analyzed optical and in-vitro data and sensor kinetics• Ran statistical analyses using Minitab to guide design selection• Contributed to design and dev of a functional opto-enzymatic sensor*Company shutdown

Irvine, California, United States

• Contributed to pilot line startup for manufacturing transfer of products approved for IDE and HDE• Created manufacturing procedures, ordered equipment and materials, and started on master validation plan*Ended early due to mass layoff of contractors

Irvine, California, United States

• Supported technical objectives of global transfer / duplication of manufacturing line• Led sample procurement activities (for all project workstreams - Training, PC, IOPQ, DVT, Type Testing, etc.) by collaborating with Supply Chain, Planning, Production, and Management • Created new product versions, GTINs, and associated finished goods drawings • Identified gaps in current processes and coordinated with base business on improvements• Ordered and shipped capital equipment • Troubleshooted and virtually assisted in training of engineers and operators• Owned and routed change orders

Greater Denver Area

• Orchestrated technical support and drove projects to improve the processes for manufacturing disposable medical products• Collaborated with Production, assisted in training production leads, oversaw verification/validation builds• Generated technical docs including change requests, change orders, protocols, reports, etc.• Drafted and executed validations and design verification, updated and created manufacturing operating procedures• Played key role in consolidating two cleanrooms, considering material flow and ergonomics• Worked with tooling designers to improve fixtures and tooling on manufacturing lines• Utilized Minitab to perform statistical analyses• Conducted studies to characterize and optimize processes

Denver, Co

• Provided extra set of eyes and hands in caring for 18 y.o. patient recovering from serious brain injury and surgery• Advocated for patient during night shift to ensure best possible care in hospital with low nurse-to-patient ratio

Co & Ne

• Observed orthopedic surgeries – arthroscopic meniscus and rotator cuff repairs, total knee replacement, ACL reconstruction, tibial osteotomy, combined ACL/PCL reconstruction, fractured femur repair, etc.• Interacted directly with physicians, patients in clinic, and medical sales representatives• Regional West Medical Center (NE) and Sky Ridge Hospital (CO)

Aurora, Co

• Collaborated with research group in the School of Dental Medicine and Department of Craniofacial Biology to create biocompatible hydrogels• Worked with research assistants and fellows, professors and students in the School of Dental Medicine, and a craniomaxillofacial surgeon• Conducted research in a materials lab• Created and tested hydrogels, nanogels, foams, and other polymers• Tested material characteristics with DMA, MTS, and IR spectroscopy

Bachelor Of Science (Bs), Chemical And Biological Engineering

Activities and Societies: CU Women's Club Soccer (President, Captain), Biomedical Engineering Society, Society of Women Engineers, BOLD.

Minor, Ethnic Studies