Sr. Mechanical Engineer @ Proteus Digital Health, Inc
Intarcia Therapeutics, Inc. @
Bachelor of Science @
University of California, Davis
I have over 12 years of experience as an engineer in the Pharmaceutical and Biotechnology industries and am motivated to continually expand my professional and personal development through new experiences and a hands-on approach. I have a mechanical aptitude and knack for consciously breaking things and putting them back together (maybe with a few leftover extra screws
I have over 12 years of experience as an engineer in the Pharmaceutical and Biotechnology industries and am motivated to continually expand my professional and personal development through new experiences and a hands-on approach. I have a mechanical aptitude and knack for consciously breaking things and putting them back together (maybe with a few leftover extra screws and a spent tube of krazy glue).
My experiences have positioned me to be comfortable in all professional interactions, whether it be on the manufacturing floor with operators, or in the conference room with leadership teams. I like to stay busy and engaged to continually challenge myself, while set higher and higher bars of success.
Specialties: Aside the from run-of-the-mill industry skill-set, i.e. Excel, Project, Visio, cGxP's, Validation, Aseptic Technique, FMEAs, DOEs, Lean Manufacturing, Flow Diagrams, etc etc. I'm uniquely experienced with CAD (Solidworks currently), 3D printing applications, packaging materials and equipment, robotics and machine vision systems, and capable with machine shop equipment.
Principal Engineer @ From May 2015 to Present (7 months) Senior Development Engineer @ - Lead engineer driving development of ~$3M retrofits for custom, pilot-scale commercial, automated fill-finish blister manufacturing line to support pulmonary products. Managed project, provided technical guidance, and performed role of primary contact with contracted global equipment supplier.
- Conceptualized, modeled, and prototyped multi-dose foil-based drug package for use with new drug-device combination product. Modified packaging equipment with R&D tooling to manufacture prototypes for product feasibility, while establishing design for manufacturing (DFM) concepts for commercial volume manufacturing capability. As a core team member, interfaced with drug and device groups to define product specs, communicate test results, and present progress on milestones to leadership.
- Worked with contract packaging organizations, contract equipment suppliers, and tooling vendors to specify design, scale-up processes, and execute qualification activities for fill/finish equipment to meet clinical manufacturing goals.
- Procure and manage global vendors and consultants for developing custom manufacturing equipment.
- Participate in facilities engineering and planning for installation of commercial manufacturing equipment.
- Source, test, and qualify prototype materials and equipment for primary blister packaging. Performed studies to determine package design for product shelf-life. From August 2009 to April 2015 (5 years 9 months) Sr. Mechanical Engineer @ - Directed validation activities for consumables manufacturing equipment used in the company’s first regulated DNA analyzer, conforming to ISO 13485. Authored and executed (or acted as primary reviewer of) equipment validation and process validation protocols. Assumed the point-of-contact role and directly managed validation contractors, completing ~$200K in contract work while under strict project timelines.
- Sourced and collaborated on design with custom equipment manufacturer for a torque controlled bottle capping system, a process improvement effort arising from customer complaints. Authored requirements document and interfaced with the vendor to ensure operations and performance goals were met.
- Developed and tested robot manipulation software programs for a multi-pipette liquid dispensing system as part of product transfer and process improvement from R&D to Manufacturing. Designed fixtures and testing tools to improve manufacturing capabilities. From March 2008 to July 2009 (1 year 5 months) Senior Process Engineer @ - Technical guidance on project team regarding mechanical design of ~$4M custom, commercial-scale, fill-finish, blister manufacturing equipment for liquid based insulin formulation. Worked closely with contract manufacturer to convey design and function to meet equipment URS. Managed and performed mechanical design retrofits while adhering to demanding project schedules.
- Experienced in tooling and processing of web material for drug packaging. Applicable processes include cold forming, drug filling, heat sealing, robotic pick and place systems, and machine vision systems.
- Performed validation activities for commercial manufacturing equipment, such as process characterization studies, FMECA, design reviews, Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). Analyzed equipment data for machine cycle time, product yield, and Overall Equipment Efficiency (OEE).
- Designed and executed engineering test protocols to verify machine functions, component designs, and performance upgrades. Performed supervisory role over technicians and operators during test execution.
- Authored SOPs relating to preventive maintenance of equipment, machine assembly, and manufacturing preparation. Supervised technical writers in development of engineering documentation.
- Interact with outside vendors to acquire custom parts, testing apparatuses, and analysis equipment/software. From April 2006 to February 2008 (1 year 11 months) Process Development / Packaging @ - Investigated drug package and medical device interface to define final packaged product specifications for commercialization of ExuberaTM. Product specifications were tested for functionality between the packaged drug product, using filling-packaging equipment, and commercial candidate medical devices.
- Member of a multi-department team developing a next-generation insulin product. Functions involve participation in QFDs, Hazard ID/FMEA, design reviews, identification of product requirements, project scheduling, designing fixtures, and manufacturing product for testing.
- Performed material properties testing on drug capsules to analyze the interaction of the device-capsule interface. Development of tests to meet product requirements definition. Designed mechanical components, fixtures, and gauges as necessary for use in testing and/or in-process checks.
- Tested design of packaging for safe transit of medical devices and components, per ASTM standards to support commercial packaging capabilities.
- Analyzed performance characteristics of a commercial-scale cyclone particle separator. Testing included, acoustic mapping to study noise and reduce vibration, temperature profiles, velocity profiles, and pressure measurements of flow paths. Results used to estimate energy distribution within the system. From June 2002 to April 2006 (3 years 11 months) Technology Development Test Engineer @ - Developed and tested measurement methods for static and transient fluid flow characteristics (per SEMI standards) of liquid flow controllers used in chemical vapor deposition processes. Compiled and analyzed test results of the study and co-authored an article for Semiconductor Fabtech Journal (14th ed., July 2001). Generated a company presentation for in-house staff and customers regarding study findings.
- Assembled and tested integrated gas systems, utilizing advanced sealing technology on surface-mount components. Tested for system leaks, particle counts and moisture dry-down.
- Performed calibration tests on state-of-the-art pressure insensitive mass flow controllers.
- Modified design of mass spectrometer gas mixing manifold to obtain precise moisture levels.
- Experimented with alternative methods of steam generation for silicon wafer oxidation. From March 2001 to November 2001 (9 months)
Masters, Mechanical Engineering @ San Jose State University From 2002 to 2005 Bachelors, Mechanical Engineering @ University of California, Davis From 1996 to 2001 Project Management for fun! @ UCBX David Yu is skilled in: Solidworks, PTC Pro/Engineer, Equipment Qualification, Validation, Medical Devices, R&D, Process Simulation, Design of Experiments, CAPA, GMP, Manufacturing, FDA, Quality System, Design Control, Root Cause Analysis
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