SUMMARY:

• Manufacturing Engineer with an extensive hands - on process & quality sustenance/control and NPD/NPI project lead experience supporting the lean manufacturing and continuous improvement activities from the US gov’t R&D laboratories, semiconductor, aerospace, microelectronics, and medical device industries
• Cross-Functional Engineering & Project Mgmt. Experience from Multiple/Medical industries
• Quality, Process, Equipment, Product, FA, Troubleshooting, Test, Technology Transfer, Project Mgmt.
• Process and Equipment Qualification, Sustenance, ATE and Bench Test Support, SMT experience
• Supported Quality Sustenance Activities
• Supported the ECO, NCMR, CAPA, MRB, PCPX/BIQ, TPM, QMS, CAPA, NC’s activities
• Led product quality nonconformance & customer returns RCFI, dispositions, & repair/rework activities
• Supported process & product quality, cycle time, and yield improvement activities
• Conducted pre-FDA inspection audit activities reviewing process validation doc’s & remediation
• Project Lead - NPI, Mfg. Start-ups/Ramping-Up, Technology Transfer, & Retooling Activities
• Led mfg. startup operations - Mfg. startup/ramping up new equipment installation, qualification, release
• Supported Tech. Transfer, Integration, & product delivery activities w/ contract manufacturing partners
• Conducted mfg. decision making activities - buy vs repair decisions, cost/benefit analysis
• Process Validation & Qualification Support
• Developed protocols & conducted new process/equipment validation (TMV, CSV, IQ, OQ, PQ) activities
• Production Sustenance and Continuous Improvement Experience (6-sigma Green Belt)
• Led and supported lean six-sigma based process yield and cycle time improvement projects
• PFMEA, Risk Analysis, Lean Six-Sigma DFSS/DMADV, DFM experience
• Work measurement studies (i.e., VSM), Time-Line Studies, Continuous Work Flow Alignment Studies
• Rapid Problem Solving & Continuous Improvement (Kaizen) activities
• Established process control (CTQ assessment, Cp/Cpk analysis, SPC process, Statistics Analysis)
• Conducted MSA, DOE, problem solving tools (i.e., 8D, 5 Why, Fishbone)
• Experience in GD&T, mechanical production & BOM setup and mgmt.
• Experience writing up & maintaining work instructions
• Assembly, operation, test, rework & repair, equipment PM procedures
• Supporting Third-Party Vendor Activities
• Project Managed - Design, fabricate, & install custom assembly & test equipment & fixtures
• Parts Supplies - Setting up BOMs, defective parts investigation, end of prod life cycle activities
• AGILE, PLM, Oracle, SQL, SAP, ISO9000, 21 CFR 820, ISO13485, Minitab, LabView
• Pick & Place tools, manual solder/epoxy/staking, bench testing/circuit analysis, AutoCAD, PLC
• Highly motivated, solid performer, & strong team player

PROFESSIONAL EXPERIENCE:

Confidential

Manufacturing Process Engineer

Responsibilities:

• Process Improvement Process/Quality Engineer
• Process owner supporting the medical product NPI projects including new manufacturing process/equipment installation, validation (FAT, SAT, Cleaning, IQ, TMV, CVS, OQ, PQ) activities
• Cortrak2 Entereal Access System, 4-Up Oral Care Fill System, MP7000 Vacuum Sealer System

Confidential

Manufacturing Engineer

Responsibilities:

• Process Improvement Process/Quality Engineer
• Supporting the lean six-sigma process yield, product quality, and throughput improvement and production line redesigning activities for the Resolute Onyx Drug Elution Stent (DES) Device production line
• Solitaire Process Sustaining Activities Support - providing engineer support to the assembly and product quality yield improvement projects including the new manufacturing tooling development and validation activities (TMV, I/OQ, PQ) - Distal Finger Welding Process, Heat Set Mandrel Improvement, EP fixture Loading Tool, Post Weld Proof Load Test Fixture

Confidential

Product Engineer

Responsibilities:

• Validation & Qualification Activities Audit (contract position)
• Supporting the internal quality audit activities in preparation for the FDA on-site inspection
• Developing the audit master checklist for use during a review of the internal ET Validation documentations
• Reviewing for accuracy and completeness of the Validation (TP, IQ, OQ, PQ) deliverables to the internal quality standards, applicable regulatory guidelines and policies (i.e., FDA 21 CFR 820, GXP)
• Supporting the cross-functional activities to identify, prioritize, and plan for corrective actions to rectify/mitigate the non-conformances (minor, major, and systematic) identified during the pre-FDA audit

Confidential

Manufacturing Process/Quality Engineer

Responsibilities:

• Production Sustenance
• Provided daily assembly & CAPA activities for test failures & defect investigation & disposition, & R&R
• Wrote up R&R work instructions & converted the work instructions to the electronic template format
• Technology Transfer Lead
• Moved & integrated the off-site contract final assembly production line to the Tempe production line
• Implemented Rapid Improvement Activities work process flow & equip layout redesign (line balancing, cont. process flow design, Ganban stations)
• Enhanced the process control for the FE & final assemblies by adding visual SPC process control tools
• Supported converting manual production travelers (assembly, R&R instructions) to the E-MES platform

Confidential

Operations Support Specialist

Responsibilities:

• A leader providing Samsung home electronics product warehouse and services
• Supervised a team of warehouse maintenance and operations support personnel for the Phoenix field site

Confidential

Sr. Manufacturing Engineer

Responsibilities:

• Supported MFD, integrating & qualifying new product to the existing production line
• Procured and qualified the custom built functional and bench test equipment and fixtures
• Wrote up work instructions and activities
• Conducting new process/equipment validation activities
• Completed the engineering prototype to production grade qualification
• Manufacturing Engr - Rework & Repair Operation
• Supported daily R&R sustenance and six-sigma continuous process and yield improvement activities
• Implemented production line balancing (VSM, & motion economy principles) & work flow redesign and replaced critical manual operations with automated tools to improve workmanship quality & process yield

Confidential

Sr. Manufacturing Engineer

Responsibilities:

• Created and executed the plant-wide product-specific six-sigma Process Control Planning and Execution (PCPX) and Built in Quality (BIQ) activities
• Led a PCPX team consisting of cross-functional engineers and production supervisors responsible for supporting plant-wide production quality nonconformance and CAPA activities
• Production Quality Sustenance (Hybrid PCB production line)
• Completed rapid improvement projects - Replacing manual operation w/ Pick & Place tools, retooling
• Updated work instructions and led operator re activities
• Led production nonconformance (damages, test fails, defective parts, etc.) RCFI and CAPA activities
• Led new/replacement equipment qualification activities (IQ, CSV, TMV, OQ, PO)
• Credited for reducing the product quality COPQ from 19% to <10% in 8 months

Confidential

Project Engineer

Responsibilities:

• A leading manufacturer of the electronic test and measurement instruments
• Technology Transfer Project Lead
• Project lead responsible for successful demonstration of building engineering prototypes using the ESM technology developed by the newly acquired R&D facility into the Chandler manufacturing facility

Confidential

Product/Test Engineer

Responsibilities:

• Led technology transfer and qualification (IQ, OQ, PQ) and process validation activities for the BE production lines moved from the off-site contract production site
• Project Lead Engineer
• Supported BE assembly & test capital & bench retooling activities - cost/benefit analysis, vendor selection, custom tooling fabrication & acquisition, installation, qualifications
• Production Sustenance
• Conducted customer return investigations and supported the CAPA for the BE production/test activities
• Conducted process improvement activities - DOE to improve lamination process, fixture modifications

Confidential

Field Process Engineer

Responsibilities:

• Support epi field process engineering activities at customer sites (Freescale, 200mm/300mm)

Confidential

Process Engineer

Responsibilities:

• Start Up Lead Engineer
• Led the 300mm wafer Diffusion/Thin Film equipment & process recipe installation, qualification & release
• Sustenance Engineer
• Wrote up work instructions for mfg. operation & equipment PM procedures and led activities
• Provided daily process & equipment sustenance, conducted RCFI investigations, led Kaizen & CAPA activities, conducted DOE studies

Confidential

Process Engineer

Responsibilities:

• Startup Lead Engineer
• Supported the NPI of the DDR and DDR2 devices including BE production assembly and test setups, product qualification, & production release activities
• Sustenance Engineer
• Provided daily production sustenance, conducted RCFI investigations, and led Kaizen & CAPA activities

Confidential

Process Engineer

Responsibilities:

• Supported installation & release of the 200mm FE Diffusion equipment and process recipes @startup
• Led installation & release of the ATE, Repair testers, and process recipes during the phase II ramping ops
• Sustenance Engineer
• Led development & release of the operating procedures (Diffusion & Test) and activities
• Conducted daily sustenance and Kaizen activities for the ATE and wafer repair activities
• Received Employees of Year 2000 for contribution to successful startup of the phase I & II startups

Confidential

Project Engineer

Responsibilities:

• Conducted R&D, assembly, & field testing of the new portable uranium irradiation detector system
• Project manager
• Led coordination & project managed development and field demonstration of the multi-DOE site remediation technology programs