Experience

FibroGen, Inc.

• United States
• Biotechnology Research
• 300 - 400 Employee

• Associate director, project management and contract manufacturing

  • Mar 2022 - Present

  San Francisco, California, United States

• Research Engineer

  • Sep 2013 - May 2022

  San Francisco Design fixtures to be used in pre-clinical development. Identify and procure equipment and materials for manufacturing. Design and generate study protocols and qualifications of manufacturing equipment. • Designed tooling and fixtures to increase production efficiency by 30%, reduced potential work injury and reduced personnel needed for parts of the operation • Reverse-engineered parts and create CAD/Solidwork drawings of the part for part improvement and usability. • Analyzed… Show more Design fixtures to be used in pre-clinical development. Identify and procure equipment and materials for manufacturing. Design and generate study protocols and qualifications of manufacturing equipment. • Designed tooling and fixtures to increase production efficiency by 30%, reduced potential work injury and reduced personnel needed for parts of the operation • Reverse-engineered parts and create CAD/Solidwork drawings of the part for part improvement and usability. • Analyzed data and offer recommendations on technical solutions to limit output effecting parameters.. • Managed outsourcing projects with value added service providers on custom materials to be used in manufacturing.



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• R&D Engineer

  • Dec 2010 - Sep 2013

  Lead weekly meetings to address project updates and technical issues for BVS Coating Team in Temecula and Santa Clara. Design and generate study protocols to test operating parameter, optimize production, and characterize outputs to establish preliminary work for setting Operational Qualification strategy. Provide guidance and direction to technicians and operators to ensure studies are conducted efficiently and produce useful results. Motivate and mentor technicians to drive career growth… Show more Lead weekly meetings to address project updates and technical issues for BVS Coating Team in Temecula and Santa Clara. Design and generate study protocols to test operating parameter, optimize production, and characterize outputs to establish preliminary work for setting Operational Qualification strategy. Provide guidance and direction to technicians and operators to ensure studies are conducted efficiently and produce useful results. Motivate and mentor technicians to drive career growth. • Managed project to coat multiple scaffolds on single mandrel to increase efficiency and coating yield for ROI of 30%. • Analyzed data and offer recommendations on technical solutions to reduce critical parameters on coating process. • Managed stent retention development project to introduce additional length of the product line . Show less



LifeNet Health

• R&D Engineer

  • Sep 2005 - Sep 2009

  FDA regulated tissue based medical implant manufacturer R&D Engineer Key accomplishments Consulted on the testing and development of new tissue products before final product design freeze. Developed and managed implementation of new product packaging to enhance product presentation, company branding, and new corporate image resulting in operating cost reduction of ~0.5% per year and increase in sale of 2-3%. Developed and implemented optimized gamma irradiation processes to… Show more FDA regulated tissue based medical implant manufacturer R&D Engineer Key accomplishments Consulted on the testing and development of new tissue products before final product design freeze. Developed and managed implementation of new product packaging to enhance product presentation, company branding, and new corporate image resulting in operating cost reduction of ~0.5% per year and increase in sale of 2-3%. Developed and implemented optimized gamma irradiation processes to increase process capacity and efficiency by 67% in order to maintain industry leader status in sterile products. Implemented robust temperature sensitive packaging system to accommodate customer needs, to reduce temperature related shipping issues by 75%, and to reduce product discard rate by 25%. Developed, reviewed and approved validations, reports, specifications and standard operation procedures. Presented new process improvement concepts to upper management and trained technicians upon approval. Show less



2005 Tissue Banks International

• Product Development Engineer

  • Mar 2000 - Jan 2009

  FDA regulated tissue based medical implant manufacturer Product Development Engineer Key accomplishments Researched new material and developed new processes for manufacturing to relieve the shortage need for 5 existing products. Capitalized previously discarded material and created a product that fulfilled a shortage need for a limited supply product and further increase product line revenue by 50%. Optimized production processing by training technicians on new developed… Show more FDA regulated tissue based medical implant manufacturer Product Development Engineer Key accomplishments Researched new material and developed new processes for manufacturing to relieve the shortage need for 5 existing products. Capitalized previously discarded material and created a product that fulfilled a shortage need for a limited supply product and further increase product line revenue by 50%. Optimized production processing by training technicians on new developed procedures and equipments New training and understanding reduced product deviations by 30%, reduced process deviations by 25%, and reduced processing time by 20%. Coordinated technological transfer with the organization and alliance partners. Brought to market five new products with alliance partners and three new products for the organization. Managed R&D projects to optimize limited resources of cadaveric tissue and man-power. Collaborated with doctors and device manufacturers to refine tissue implant designs. Show less