STEPHANO CHO LIVERMORE, CA 510-***-**** ad39ww@r.postjobfree.com

SUMMARY

20+ years of engineering experience working in fast-paced and high-volume production environment of medical device industry, with responsibilities spanning product and process development, new-product transfer, equipment qualification, process validation, and manufacturing under QSR/cGMP/ISO controls.

5+ years of experience in Semiconductor and Optics industries.

Dedicated team player, motivated self-starter with demonstrated technical/mechanical/chemical acumen.

Seeking a position in a growing medical-device company, where I will leverage my experience to contribute effectively to cost-reduction and capacity-expansion initiatives, while driving continuous improvements in product quality.

PROFESSIONAL EXPERIENCE

Clip Health (Fremont, CA) 12/2020 – 12/2022

A California-based start-up diagnostics company with a mission to increase healthcare accessibility and efficiency with funding by the National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA), to develop and manufacture a rapid smartphone-based point-of-care diagnostic test for the detection of SARS-CoV-2 antigens.

• Process Engineer

- Provide technical support to all equipment and process related issues that occur during the 24/5 manufacturing operations.

- Responsible for transfer (development to manufacturing), scale-up, semi-automated equipment qualification, process validation, and optimization of high-volume manufacturing processes for diagnostic products. In-scope products include finished lateral-flow cartridges, critical reagent sub-assemblies, and analyzers.

- Tasks includes characterization, optimization, and troubleshooting of manufacturing processes while evaluating existing manufacturing processes and equipment to reduce cost, improve sustainability, and develop best practices within the manufacturing environment.

- Work in a general laboratory and wet-chemistry environment, including safe handling of biological materials, formulation, web-processing, and finished-product assembly for lateral-flow diagnostic products.

- Author manufacturing procedures, deviations and validation protocols and reports; provide training to manufacturing associate to the new procedures and protocols prior to execution. Highlighted Achievements

o Successfully performed IOPQ and PV for the new production line (including the Kinematic Matrix 2210 Laminator, the Matrix 2380 Assembly Machine, the Sonitek Thermal Press, the QuickPouch Sealer, and the Plexpack Sealer) to support the launch of Covid product in a timely fashion. o Setup and qualified the new manufacturing dryroom for production. o Developed and validated benchtop band sealers and custom-fabricated extraction jigs for production. o Implemented new 16-cavity cartridge housing molds from two (2) suppliers to produce consumables for manufacturing; performed engineering studies to verify fit and process-ability on equipment. Also, analyzed part dimensional data prior to mold acceptance.

Abaxis, Inc. (a Zoetis Company) Union City, CA 08/2010 – 12/2020

A leading provider of point-of-care diagnostic tests for the medical and veterinary market. Zoetis is the world’s largest producer of medicine and vaccinations for pets and livestock – $6.3B revenue.

• Sr. Manufacturing Engineering Technician

- Supported daily production and troubleshooted plastic related defects found on the line or during incoming inspection and provided recommendations to address issues, maximize yield and minimize production downtime.

- Performed root cause analysis on defects across the four (4) injection molding plastic components (base, cover, barcode ring, and diluent cup) through detailed inspection, capturing issues with high resolution images and relaying information to Quality and molders.

- Worked closely with the Plastic Engineer to execute engineering studies to develop the new multi-cavity injection molds and maintain the existing molds for production.

- Executed IOPQ on several new and upgraded semi-automated equipment for production.

Highlighted Achievements

o Conducted a series of DOE to develop a new “cover-to-base” welding process on the Branson 2000X 20kHz Ultrasonic welder along with the 1:1.5 gold booster and the leveling plate with the objective to minimize bead dusting and improve weld consistency. A final proposal with recommendations of a new process window and new welding system configuration was presented for management review. o Performed IOPQ on the fully automated workcell equipped with the new Branson 2000X 40kHz ultrasonic welder. o Qualified and implemented one new 8-cavity mold for the Rotor cover and one new 8-cavity mold for the barcode ring to improve inventory capacity; worked extensively with the cross-functional teams (Operations, R&D, Quality) to develop test plan, FMEAs, and validation strategy.

o Developed a new 4-cavity base mold with the conformal cooling design and EDM finish to improve part quality and reduce material cost; involvement includes various stages of mold development through visual assessments and Metrology tests (CMM, ZYGO Optical Profiler, and Test instruments) along with statistical analysis through utilization of tools such as EXCEL, Minitab, and JMP. Other requirements include lab chemistry testing with analysis and review/presentation of results.

Cholestech, Corp. (an Inverness Medical Innovations Company) Hayward, CA 11/2004 – 2/2010 A leading provider of point-of-care diagnostic tests for lipid profile, glucose, HbA1C, and liver enzymes for risk assessment and therapeutic monitoring of heart disease, diabetes and inflammation – $70M revenue.

• Process Engineering Chemist III

- Supervised daily manufacturing operations and material management for the hs-CRP product, including:

Equilibrium Monitoring Testing of new cassette lots with data analysis using JMP and Excel.

Performing In-Process QC Tests for new lots of treated sub-components.

Generating and performing experiments to troubleshoot and mitigate issues.

Coordinating schedules with Production Chemists for formulations and coating of sub-components.

Conducted in-process QC testing for Lipid and ALT/AST products.

- Supported new product development (Lipid/ALT, d-LDL, Cardiac hs-CRP, and Wide Web Center Glass).

- Generated documentation – Standard Work Instruction/Operating Procedure (SWI/SOP), Batch Record, Process FMEA, Engineering Change Order (ECO), Document Change Notice (DCN).

- Scheduled and trained new associates in testing, equipment operations, and data analysis.

- Developed expertise with the following equipment and processes:

Rotary Slitter (slitting membrane and center glass)

Coater with convection dryer (coating membrane, center glass, and porex)

Dispenser/Dryer (dispensing reagent formulations onto membrane)

Thermal Welder (welding coated membrane onto plastic reaction bars)

Laser System (laser cutting membrane) and De-chipping Station (de-chipping of membranes after laser cut)

Pick and Place Workstations (cut and place laminate strips onto plastic sub-components)

Laminators (laminating several components into card-based sub-assemblies). Highlighted Achievements

o Performed IOPQ on new equipment – Kinematic/Biodot Slitters, De-chipper, Laser-Cutting System. o Performed lab testing in support of obtaining Certification for Total and HDL Cholesterol by the CDC’s Cholesterol Reference Method Laboratory Network (CRMLN) in 2007 and 2009. o Performed lab testing and data analysis in support of maintaining Quarterly Certification for Lipid Standardization Program (LSP).

LifeScan, Inc. (a Johnson & Johnson Company) Milpitas, CA 11/2002 – 11/2004 A leading maker of blood glucose monitoring systems for home and hospital use – $1.5B revenue.

• Process Technician - SureStep Reagent Operations

- Manufactured glucometer strips through various stages of processing, under tight cGMP, SOP and safety controls.

- Prepared liquid reagent formulations on the 10-liter scale, under tight tolerances for activity and pH.

- Applied reagent solutions to blood-separation membrane using Hirano Tecseed Coater.

- Assembled sub-components into completed web reels, including baking/drying of Porex and Melinex rollstock.

- Conducted product QC testing in blood lab (including selection/randomization of test samples and maintaining blood- sample glucose concentrations within tight bands by spiking, verifying with YSI Model 2100 Select Glucose Analyzers). LaserTel, Inc. Tucson, AZ 11/2000 – 07/2002

A worldwide supplier of high-power semiconductor laser diodes, including array packages, fiber-coupled packages, diode bars & chips.

• Process Technician

- Operated and maintained equipment for the production of GaAs wafers in a clean-room environment.

- Lapping and polishing, dicing Silicon wafers, wet and dry etching, metal deposition, annealing, photolithography, facet coating, and inspection.

- Investigated wafer process and implemented improvements that reduced cost and production time.

- Interacted with production, maintenance, and engineering groups on relevant process issues.

- Troubleshoot process and tool related problems.

- Trained associates in operating equipment and handling of materials.

- Assisted in locating and ordering materials and parts needed for any phase of the process.

- Chemicals used: Acetone, Methanol, Isopropyl Alcohol, Phosphoric Acid, Hydrochloric Acid, Sulfuric Acid, Ammonium Hydroxide, Buffered Oxide Etchant, Gold Etchant.

- Equipment used: Logitech Lap and Polisher, CHA E-Beam Evaporator, K & S Dicing Saw, Karl Suss Mask Aligner, Oxford Plasmalab 800 P.E.C.V.D, Oxford R.I.E, Loomis Scribe and Cleave, Steag Rapid Thermal Processor, Four-Point Probe, Ellipsometer, Tencor Alpha Stepper.

BEAMLINE TECHNOLOGY CORPORATION Tucson, AZ 01/1997 – 08/2000 A developer of high quality, beamline components, custom beamline systems, synchrotron optics, and high-energy laser optical components and coatings.

• AutoCAD Designer / Processing Operator

- Drafted mechanical designs of optics and machine parts using AutoCAD LT.

- Grinding and polishing of Synchrotron Optics to less than 5 angstroms of roughness.

- Measured optics using WYKO TOPO 2D Surface Profiler.

- Materials used: Glass, Fused Silica, Ule, Single Crystal Silicon, Silicon Carbide, and Nickel-Plated Aluminum.

EDUCATION

ITT Technical Institute May 1995 – November 1996

Associate of Applied Science in Computer-Aided Drafting/Design

Study courses include Mechanical, Architectural, Engineering, Electronics, and Project Management.

Diazo machine and plotter

Honors / Perfect Attendance

University of Arizona August 1991 - December 1994

Completed over 60 credits in General Studies and Management Information Systems.

SKILLS

Working knowledge of the Windows environment and Microsoft Office.

Proficient in Minitab and JMP statistical software.

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