San Jose, CA 95132
PROFESSIONAL Self-reliant, precise Manufacturing/Process Engineer with a Master’s Degree and 15+ years
SUMMARY of successful ensurance of quality and compliance in medical device, wafer fab, mechanical system, electro/opto-mechanical design and manufacturing. Proficient in reliability assessment, failure mode and effect analysis, process development, testing, ISO 9001, ISO 13485, RoHS, document control and new product integration through all PLC phases. Leverage knowledge of 5S Lean/Kaizen tools and GMPs to implement solutions that improve efficiency while reducing waste, handling and cost. Familiar with injection molded, extruded plastic parts.
• Highly analytical with “big picture” vision and the ability to work with management, staff, customers and vendors to convert complex component and system requirements into practical, cost-effective designs.
• Master problem solver, with ability to rapidly get to the root cause of a problem and execute a workable solution.
• Fast-paced, flexible senior-level contributor, adept at staying on-task and on-time with deliverables despite shifting priorities and aggressive deadlines.
TECHNICAL Solid Works, PRO-E, BOM, DFx, ECO/ECN, OMS, DOE, FMEA, SOE’s/SOP, SPC, Kaizen,
SKILLS 5S, NPI, MRP/ERP (Agile, Visual, Oracle, SAP), MRB, MS Office, Visio, Adobe, 6 sigma
PROFESSIONAL Intuitive Surgical Inc., Sunnyvale,CA 02/2012- PRESENT
EXPERIENCE Manufacturing Engineer (Contractor, Advantage Tech. Res.)
Actively working on Design for Environment (DFx) for custom/COTS parts manufacturing
process and specification to comply with RoHS directive (2002/95/EC), also rolling up to
main assy in the BOM from bottom level parts for RoHS compliance in the Agile. Creating,
routing and implementing MCO/ECO in Automated Change Control System (Agile) which
includes validating parts, updating drawing (CAD), specification,DOP and BOM. Working
with suppliers, contract manufacturers, procurements, document control, product manager
and regulatory affairs. Working in ISO 9001, ISO 13485, 21 CFR 820, GMP compliant
environments. Updating MPI’s.
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SEMITRAC, Santa Clara, CA 01/2010 – 02/2012
Process Test Engineer (Part-time Consultant)
Vital technical resource qualified and tested for new products and components (MFC, FRC, VALVE) for gas delivery system used by semiconductor capital equipment manufacturer. Designed and executed comprehensive test plan with customer to measure desired output, verified each step of recipe, monitored temperature/pressure/flow rate of corrosive gases, collected data, analyzed results and edit recipe as needed using LabVIEW.
Key Accomplishments:
• Took ownership of each project from start to finish, achieving all expected results.
• Qualified and tested many products in aggressive timeframe, meeting critical customer delivery deadlines.
• Kept in constant touch with customers to supply/analyze feedback on test result data.
• Proactively modified recipes on the fly vs. waiting for end of the test run, leading to work completion in 3 weeks vs. estimated 4.
Boston Scientific, San Jose, CA 04/2009 – 06/2009
R&D Engineering Tech (Contractor, BBSI)
Created and reviewed new/existing components spec datasheet for RoHS (Restriction of Hazardous Substance) for European Union compliance. Reviewed and updated computer- aided printed circuit board layout (PAD), printed circuit assembly (PCA) and PAD schematic PDF drawing of PCB. Prepared docs for change request and online approval. ECO/ECR creation and submission online using Matrix One with limited access.
Key Accomplishments:
• Replaced obsolete PCB components with new RoHS compliant components.
• Completed all changes on-time and worked closely with RF system manufacturing vendor to ensure products were delivered to customers in required timeframe, with updated components (RoHS-compliant).
• Contributed to 21 CFR 820.100 CAPA (Corrective & Preventive Action) activities.
Ultra Clean Technology, Hayward, CA 10/2007 – 10/2008
Mechanical Manufacturing Engineer
Provided high-level technical support to production floor and assembly in Clean Room Class 1000 environment. Resolved issues relating to drawing, paint, coating, polishing and surface finish, assembly drawing interpretation and rework of chemical/gas delivery system. Designed and updated work instructions on Process Control Systems and Operational Method Sheets (PCS/OMS). Monitored and implemented In-Process QC/QA checkpoints and supported implementation as needed. Created all Manufacturing documentations.
Key Accomplishments:
• Guaranteed process was error-proof and efficient by generating root cause analysis and corrective action plans with Failure Mode & Effect analysis (FMEA) and DFM (DFx), affecting both customer and company.
• Drove continuous process improvement using Kaizen and 5S principles. Successfully reduced cycle time and motions on the floor 20%, through a 5-day redesign project that redefined work cells with 5S Lean tools/principles. Significantly decreased non-value added ac...
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