Shannon Smith

About Shannon Smith

Dynamic and results-driven professional with an analytical mindset and comprehensive experience in product design and development, data analysis, project management, and process improvement.Recognized for end to end development and sustaining products within a regulated environment, specializing in risk-based approaches for reagent and product characterization. Highly skilled in product design and optimization, statistical analysis, staff training, and product development engineering at systems level. Adept at conducting data analysis and employing rational approaches for effective problem-solving and continuous improvement initiatives. Experienced in formulating plans and structuring processes to streamline operations and timely complete projects. Proficient in analyzing, organizing, documenting, and effectively communicating scientific data, proposals, progress, and feedback to both technical and non-technical audiences across various forums.Key achievements: • Led rapid improvement event for the high-volume product line, yielding a funded proposal with potential 5-year cost savings of $2-8.5M based on selected strategies. Leader of 8D and Six Sigma approaches.• Devised knowledge management resource for 40+ products used by 700+ employees, boosting risk management, design changes, onboarding, and product development:o Achieved significant time reduction from weeks to minutes for answering inquiries, supporting 50+ investigations, and facilitating design changes.• Liaised with quality, operations, process engineering, customer support, marketing, R&D, and bioinformatics teams to ensure efficient product development & sustaining efforts and successful project deliverables.• Recognized as a key contributor to the development of FDA-approved MiSeqDx Extended RAS Panel Assay (CDx) in June 2017:o Headed multiple crucial FDA-submitted studies, including Extraction Kit, Limit of Detection, Lot to Lot, Specimen Comparison, Workflow Timing, Specimen Handling, and PCR Thermocycler System Comparison.• Consumables system engineering member of NextSeq XLEAP chemistry development program

Experience

1. Senior Staff Product Engineer

   Illumina

   Dec 2024 — Present · San Diego, CA, US

Education

• Mayo Clinic Graduate School of Biomedical Sciences

  Master of Science (MS), Biomedical Sciences Immunology

  2007 — 2010

• Humboldt State University

  Bachelor of Science (BS), Biology emphasis in Cellular/Molecular Biology

  2003 — 2007

Skills

• Pcr
• Flow Cytometry
• Sds-Page
• Biomarkers
• Hplc
• Life Sciences
• Genomics
• Polymerase Chain Reaction (Pcr)
• Immunohistochemistry
• Qpcr
• Tissue Culture
• Research Design
• Biochemistry
• Data Analysis
• Western Blotting
• Cancer
• Protein Chemistry
• Cell Biology
• Sequencing
• Gel Electrophoresis
• Biotechnology
• Protein Purification
• Assay Development
• Cell Based Assays
• Cell Culture
• Dna
• Molecular Biology
• Real-Time Polymerase Chain Reaction (Qpcr)
• Rna
• Genetics
• Lifesciences
• Immunoprecipitation
• Elisa
• Aptamers
• Dna Sequencing
• Reverse Transcription Polymerase Chain Reaction (Rt-Pcr)
• Rt-Pcr