Steve Nakashima

About Steve Nakashima

Process development and quality engineer with more than twenty years experience in people management, product development, manufacturing, and quality assurance. Demonstrated management ability with staff and budgets, internal and external product transfers, and establishing product specifications. • Product Commercialization • Project Management • Technology Transfer• Team Management • Process and Product Development• Quality EngineeringI have always enjoyed puzzle games and toys growing up. Even today, I still enjoy Logic and Sudoku puzzles and the satisfaction of finding the solution. This passion led me to pursue a degree in engineering and eventually a career. I started my career with Applied Biosystems. From DNA Synthesis and Protein Sequencing to PCR and DNA Sequencing, Applied Biosystems gave me the opportunity to work with a company that was providing tools (instruments and reagents) that could help improve the human condition. I have the unique background of working in manufacturing, quality assurance, and research and development. This has given me the perspective of being able to bring all three together and improve the process for transfer of products into manufacturing.

Experience

1. Manager, Quality Engineering

   Guardant Health

   Jan 2021 — Present · Redwood City, CA, US

   Manager, Quality Engineering, Reagents, 2024 - PresentStaff Quality Engineer, 20••••24• Support all quality activities for reagent manufacturing and process development activities including equipment qualification, pFMEA, test method validation, process validation and process monitoring.• Providing guidance for production and process controls, risk analysis and decisions on process validation to ensure continued compliance with internal procedures in accordance with FDA Quality System Regulations, ISO 13485, CMDR, CLIA, CAP and applicable state requirements.• Providing guidance to cross-functional teams responsible for the implementation of process changes and improvements.• Providing guidance on risk-based sampling and statistical methodologies relevant to manufacturing.• Supporting transition of manufacturing processes from design to production and ensuring that all design transfer activities are completed prior to product launches.

Education

• University of California, Davis

  B.S., Chemical Engineering

  1986 — 1991

Skills

• R&D
• Technology Transfer
• Biotechnology
• Quality Assurance
• Validation
• Life Sciences
• Sequencing
• Product Development
• Molecular Biology
• Commercialization
• Pcr
• Lifesciences
• Manufacturing
• Protein Chemistry
• Capa
• Fda
• Dna
• Gmp
• Process Simulation
• Chromatography
• Dna Sequencing
• Spc
• Process Development
• Project Management
• Packaging Engineering
• Research and Development (R&D)