Daron Fong Email & Phone Number

Pleasant Hill, Ca, Us

Bad Homburg, Frankfurt, De

Manages complex design transfer/sustaining projects for multiple Class II Medical Devices from inception to completion

Bad Homburg, Frankfurt, De

Manages and executes design transfers, process improvements, and new process implementations for two Class II Medical Device product lines (Hemodialysis and Crit-Line).Primary Project Manager for new rework process/production line, allowing site to rework and release over $34M worth of Hemodialysis machines under a previous FDA Sales Block.Partner with Software team to plan, develop and prioritize requirements, perform User Acceptance Testing, and deploy new software applications.Created and acted as program manager for site's Internship Program (2022), resulting in the hiring of three interns, with two converted to Full-Time Manufacturing Engineers.

Bad Homburg, Frankfurt, De

Implemented a new in-house production line for a peritoneal dialysis pump, which resulted in cost savings of over $1 million annually and improved quality outcomes and traceability. Managed and oversaw all facets of the project, including ten new sub-assembly processes, construction of a Controlled Environment Room (equivalent to ISO-8 clean room), and training of 12 operators with a capital budget of $600K.Responsibilities include design, testing, and implementation of fixtures and tooling for manufacturing; Process/Work Instruction development; Process and Equipment validation; change management; vendor management, and technical troubleshooting.

Managed installation, validation, and new maintenance plans for a $500K centralized RO Water system.

Concord, Ca, Us

Project initiation and project engineering tasksSetting up SharePoint sites for team usage, as well as setting up communications and document control protocolsSupport assembly of design engineering package and P&IDs, coordinate with vendors to provide correct parts and services, review and verify parts lists and conduct field walkdownsDraw, redline, and review piping and instrumentation diagrams (P&IDs) using AutoCAD software

Concord, Ca, Us

- Utility Plant Operator in a joint program for engineers to learn plant operations. - Qualified in the operation of over 18 GMP and non-GMP utility systems, including Water-for-injection (WFI) distillation stills, RO skids, Clean Steam Generators, Air Compressors, etc. - Responsibilities included: performing routine/non-routine maintenance on utility systems using Lockout-Tagouts, troubleshooting systems using technical manuals, P&IDs, and operator knowledge, and responding to emergency situations to maintain plant operations

Learned the basics of studio photography, client interaction, and logistics of a small business operation.

South San Francisco, California, Us

Performing and aiding preventative maintenance on utilities systems at CCP1 in Genentech's Vacaville site; also shadowing and aiding operators in daily maintenance and operational duties in the facility. Also utilize Piping and Instrumentation Diagrams along with field experience to assist in production of new training materials.

Concord, Ca, Us

Coded in C#, SQL, XML to help develop functionality for an Operations Procedure and Maintenance Instructions processing software called P123 and support creation and management of databases for client refineries.

New York, Ny, Us