SUMMARY

• Strong capability to quickly get on work & solve problem under different working environment (Solid engineering background/experience & intelligent analysis apply to any type of engineering work) with approved track
• Experience of design/manufacturing process in medical device / FDA CFR 21 Part 820, ISO 13485, ISO 14971 environment, FMEA.
• Experience from concepts to application in lean 6 sigma, PPI, Value stream, Kaizen/5S, ISO Audit, process verification & validation, Statistics analysis - Minitab (ANOVA, DOE, Gage R&R etc.)
• More than 10 years of experience in physical & thermal design, product development-Research /Research /qualification/analysis/prototype/testing,
• Design, development & localization on different generations of equipment / devices as a lead engineer. Experienced in the field support & vendor management.
• Strong technical management skill and excellent communication and team work skills. Demonstrate a drive & take initiative to achieve goals in a fast paced environment

TECHNICAL SKILLS

• Pro/E
• SolidWorks
• Flotherm
• ANSYS
• Pro Mechanica
• ABACUS
• Solid Edge
• MathCAD
• Minitab/Statistics
• MS office
• Testing/Mock-up set-up
• Six Sigma
• FMEA Knowledge
• GD&T experience/knowledge.

PROFESSIONAL EXPERIENCE

Confidential, Bridgewater, NJ

Process Quality Assurance Engineer

Responsibilities:

• Process Improvement - Filling line production bottle neck/issues (Filling & Packaging), productivity analysis - increase 20%, streamline the process for ACROS (PPI project), router setup and standardization, SOP/Work Instruction/review sheet/equipment setup.
• Customer Compliant - Processing, coordinating responding, summarizing and presenting customer complaints daily. Complaint Review Board, Complaint Process map, SCAR response. Risk assessment (FMEA) on customer complaint.
• Root Cause Analysis & CAPA - All leakers (Bottle/Keg/Pail/Drum), contamination (Local & system), label, and etc., CAPA issue/tracking/engineering fix & review.
• Validation - Bio-Water System, review/approve protocols, evaluate process & criteria, monitor execution and review final report.
• Supplier Quality - OEM complaints, root cause/Risk analysis & recall/credit (Leakers, permeation, contamination, packaging, label & etc.), SCAR, OEM Quality evaluation (CQS -Certified Quality Supplier, SOP -Score Card, CQS Approval Procedure)
• Others - NCMD/NCMR, NCMD Review Board, NCMD Risk Assessment, ISO Audit, Internal/Customer Audit, Sample size, Minitab/Statistics, KPI Board

Confidential - Somerville, NJ

Quality Assurance Engineer

Responsibilities:

• Data and Root Cause Analysis – Daily evaluate/review multiple production lines data against the spec., Root cause and cost impact analysis on the off the spec. Root cause analysis on the quality issues on Wrinkle, curl, uneven bond strength and etc. CAPA project on adhesion degradation.
• Recall & Customer Audit – Information preparation.
• SPC - Development of Template for Production, Training operators on SPC
• Projects of Capital Expense – Auto vs. Manual (2 Extruding LDPE Lines slitter), Die sizes comparison vs. scrap (Extruding Line COC & LDPE)
• Process Improvement & Engineering - DOE project to Increase productivity by optimizing line speed, constant tension with adjustments of load cell, infeed nip, hot/cold nip impression, treater power. Parameter recipe on different mfg processes. Setup & changeover time reduction (Quick setup tool or jigs). Rewind capacity increase (Upgrade rewinder). PM programs/procedures. Production floor mapping, oxidizer inspection, data acquisition system. SOP/WI/Training for all equipment & lines (Laminator, Slitter, Extrusion and etc.), PFMEA.
• FAT – Dusenbery slitter Factory Acceptance Test protocol writing/executing and final report
• Validation – Requested by GTC, OQ/PQ protocol/execution on either new materials (Cost reduction) or new customer products, VapoShield (Aclar), Gallazzi PVC, PX10, 200 PCTFE (Vaposhield), VA / VPA Lamination using AW2 (Glue), VAV and etc.
• Multiple New Product Trials & Material Property Study - Pre-corona treatment, VAV Haze test, thermoformability, coating cylinder sizes, Hopper Scale, extruding uniformity, Extruding line balancing (Input/output).
• MUV Projects (Material Usage Variance) – Evaluation of all current mfg processes/lines (Extruding, laminating, & slitting) scrap factor vs. router/setting, setup, changeover, edge trim and etc., propose to reduce scrap factors and save million dollars.

Confidential

Lead Process Development Engineer

Responsibilities:

• Process & Development – Coating Process/Spray Equipment: Design, Development, Analysis, Set-up, Verification, Validation (OQ/PQ-Execution), Risk Analysis (PFMEA/DFMEA), Optimization (DOE), Yield Analysis/Improvement, Process Flow Chart.
• Manufacturing - BOM & Routers setup in PDM & SAP System, Design/Process Transfer to Mfg, Yield Analysis & Improvement, Flow Work Training, NPI, Technical Support to Mfg. Incoming / Receiving Inspection Procedure w. QA & Shipping/Receiving Team. Manufacturing Issues, Preventative Action (Spraying System Nozzle Misalignment, Spraying Nozzle Clog, Spraying Mesh Cleaning, and etc.), Productivity Analysis.
• Testing/Set-up/Procedure/Plan/Testing Equipment (Daily Base) - Process requirement test (Add-on), Test Procedure/Plan, Product Requirement Test (IQ, Shear, Axial stretch, Kink, Water Intrusion, SEM, Mock-up, Solubility, Mixing, Uniformity, Vendor equipment, Spray Pattern, ESD & Reduction, Airflow, Thermal Mapping, Noise & Vibration, Speed/rpm), Cross Contamination/Handling, All Hands-on Testing – Instron.
• Design & Analysis / Vendor Management - Spray Equipment Modification, Prototype, Testing Fixture, and Production Fixture using SolidWorks & GD&T Knowledge, Equipment Cost Analysis, Process Capability Analysis, and Statistics Analysis using Minitab, Testing Data Analysis
• Document - IQ/OQ/PQ Protocol Writing & Report, Study Protocol, Specification, WI (Manufacturing Procedure), Inspection Procedure, Notebook Study, PM (Fusion Spray Coating, Fusion Knitting, Bead Wrap, Serialization, and etc.)
• CAPA - Graft kink due to uneven compression (Vision system introduction into mfg. loose knit & shear bond strength caused by glue unevenness along multiple positions during spraying (Misalignment of Nozzle Issue - 3 years old issue solved).
• Vendor - IVEK Vendor Nozzle Verification (Gage R&R) & Process, Equipment Loan Testing
• DOE Project - Fusion Spray Process Verification, Productivity Improvement w. Optimizing Process Parameters (Pressure, Flow Rate, Standoff Distance, Rotation Speed, Drying Time and etc.). Yield Improvement Activities (Orientation Change, Chuck Hold Head Replacement, Drying Time Reduction),
• Other Involvement Packaging Input - Folding Barrier for Graft), Simple PLC Interface Box & programming, Process/Improvement/Verification: Antimicrobial/ Bio-Gate, PTEE SS Expansion, Stage II Sprayer Configuration/Deployment, R55 Anti-Static ESD Nozzle Implementation, FM ESD Graft attraction, FM Removal Equipment, Fusion/Bioline Product requirement test (Instron), Dipping Fixture, Spray Pattern Fixture, Fume Hood Airflow mapping, IVEK Nozzle Incoming Verification Process, Collagen/Silver Acetate Coating Application, Manufacture Issues (Sprayer Stop, PLC Freeze, Gear Box, Connector Broken, and etc.), PA (Nozzle Clog, Mandrel Cleaning Procedure), Vision Measurement System.

Confidential, Whippany, NJ

Lead Engineer for Thermal & Physical Design

Responsibilities:

• Design - Manage Projects From Concept to Product Launch on Thermal Management of Wireless Base stations (Board Level, Shelf Level & Cabinet-System Level), Concept, Analysis-Calculation (Pressure Drop, Airflow Requirement, Solar Load, Heating Power, Temperature), Simulation (Flotherm, Pro Mechanica & ANASYS), CAD Design (Pro-E & GD&T Knowledge), Specification Writing/Updating, Vendor Design/Verification of Cooling/Heating Element/Enclosure, Fan Tray, Front/Rear Heat Exchanger, Assets Arrangement/Optimization/Compromise, Cost Reduction, Geographical Design Arrangement, Competitor Product Analysis, MTBF, L10
• Verification / Testing - Mock-Up Test on airflow and Temperature (Board/Shelf/Cabinet-System Level), Vendor Prototype Test/verification (Airflow, Pressure, Velocity, rpm vs. temperature, displacement & acceleration test arrangement for Shock/vibration test), Dynamic Balance, Salt Fog, Cold Start, EMI Interference, FCC/Telcordia (formerly Bell Core), UL, Corrosion, Water, Drop, Vibration, Noise, Heat Sink, Wind Driving Rain, Stress/Strain, Speed of Air Movers, Solar Load, First Article
• Vendor Management - Identify & Qualify Vendor, Weekly Vendor Meeting on Product Development Status/Issue, Common Input on Field Issue. Vendors involved in from Air Cooling to Liquid Cooling (Heat Sink) are NMB, Comair, Thermacore, EBM, APW McLean, Nippon Denso, AAVID, Honeywell, Pentair, Some German & China Suppliers
• Cost Reduction /Localization - Idea Input on Cooling/Heating Product Cost reduction, Support Localization in China, Brazil, Mexico & Poland
• Product / Project / Involvement - OneBTS Wireless Base stations of Phase 1 ~ 5, Modcell 1.0/2.0, Compact cell, Compact Lite, Microcell, Compact cell (Hybrid), Flexent, Series II M/MM, Flat Heater / Top Heater for Cold Start, Variable Speed Air Mover, Front/Rear Heat Exchanger, Cost Reduced Project for Variable Version Base stations, Flap Exhaust Design