SUMMARY:

• With over ten years of experience in advanced technology industries: Medical Device / Semiconductor / Aerospace/Avionics industries. Recent experience includes medical device industry/pharmaceutical clean room system validation, and medical device validation protocols including TMV, IMV, as well as IQ, OQ, PQ and PPQ.
• All documentation for the value stream
• Experience with basic component engineering including, part parameters, specifications, etc. Experience with revision control of specification. Responsible for ECR/ECO Execution
• Cost and scrap reduction
• New Product Introduction (NPI) and authoring/execution of validation protocols
• Continuous improvement; increasing efficiency utilizing ISO 2001; ISO 13485 guidelines
• Product testing and troubleshooting
• Supplier’s quality audit
• Customer interface
• Technical support to buyers as well as to the customers
• Process stream lining via lean manufacturing methodology

TECHNICAL SKILLS:

SKILLS: Microsoft Office (Power Point, Excel, Word), Mini Tab Solaris Sun Working in UNIX, Oracle applications AutoCAD /Or cad / Visio, Lab View, Mat Lab C++, FORTRAN, BASIC & SPICE Frequency generators, Oscilloscopes, DVM, Analyzers and meters Member of Failure Review Board (FRB), MRB and FRACAS teams. Certified Six Sigma Specialists. Certified in ESD, Electrical Safety and Clean Room Practices Certified of Lean, 5S and Kaizen team. Identify opportunities to improve Electrical Manufacturing Engineering. Practices and implement as required

PROFESSIONAL EXPERIENCE:

Confidential, Irvine CA

Validation / Manufacturing Engineer

Responsibilities:

• Prepared pilot and validation report, as well as BOMs, component drawings and manufacturing procedures
• New Product Introduction (NPI) and authoring/execution of validation protocols.(CENTERA and ALTERRA Products)
• Prepared and reviewed validation protocols and final reports (IQ, OQ and PQ). Developed and revised standard operating procedures (SOPs). Assisted with equipment selection and specification. Coordinated the approval of quality plans and protocols. Tested and troubleshot various electronic circuits & equipment malfunctions. Provided technical support to technicians for atrial fibrillation (Catheter Products)
• Improved product and process design by writing engineering change notifications (ECN, ECR & CAPA).
• Interfaced with R&D, manufacturing, clinical affairs, quality and regulatory personnel to ensure compliance with internal and external policies and procedures, FDA regulations.
• Manage product testing against approved protocols.
• Ensure compliance to quality requirements.

Confidential, Tustin, CA

Sr. Manufacturing Engineer

Responsibilities:

• Prepared pilot and validation report, as well as BOMs, component drawings and manufacturing procedures
• Prepared and reviewed validation protocols and final reports (IQ, OQ and PQ). Developed and revised standard operating procedures (SOPs). Assisted with equipment selection and specification. Coordinated the approval of quality plans and protocols. Tested and troubleshot various electronic circuits & equipment malfunctions. Provided technical support to technicians for atrial fibrillation (Catheter Products)
• Improved product and process design by writing engineering change notifications (ECN, ECO & CAPA).
• Maintained calibration and NCR record for internal and ISO audits
• RFA (Request for Analysis): when any complain related with manufacturing and its need to be further investigation for root causes to provided information to Manufacturing Engineering of the floor and RnD department

Confidential, RANCHO CUCAMONGA, CA

Customer Support Engineer

Responsibilities:

• Installed and updated the Rx Software in hospitals/pharmacies to increase productivity and reduce down time.
• Successfully managed and maintained test equipment. Provided technical support to doctors & pharmacists.

Confidential, IRWINDALE, CA

Validation Engineer / Manufacturing Engineer

Responsibilities:

• Prepared pilot and validation report, validated BOMs, drawings and procedures.
• Collected equipment calibration data, test results validation protocol development, Cpk, Cp, SPC, hard agaging applications, for laboratories, research and manufacturing environments in the medical device industry, polymer extrusion catheter products. Troubleshoot problems with production and take corrective action. Researched the purchase of equipment and implemented upgrades to existing equipment. Analyzed and improved manufacturing methods in mass production.
• Interfaced with R&D, manufacturing, clinical affairs, quality and regulatory personnel to ensure compliance with internal and external policies and procedures, FDA regulations.
• Prepared and reviewed validation protocols and final reports (IQ, OQ and PQ). Developed and revised standard operating procedures (SOPs). Coordinated the approval of quality plans and protocols.
• Improved product design by writing Engineering Change Notifications (ECN, ECO & CAPA).
• Maintained calibration and NCR records for internal and ISO audits.
• Assisted quality engineering with process improvements and quality audits.
• Monitored, Analyzed and Generated Non Confirming Material (NCR) disposition and closure.
• Performed source inspection and manufacturing process audits at vendor facilities.

Confidential, LOS ANGELES, CA

Product Engineer

Responsibilities:

• Planned, managed, and documented projects involving the Misterium (Mini Sterile Modular Room) and associate clean room utility systems. Proposed and implemented upgrade projects for existing manufacturing and utility systems. Interfaced with R&D, manufacturing, clinical affairs, quality and regulatory personnel to ensure compliance with internal and external policies and FDA regulations.
• In depth knowledge of pharmaceutical clean room systems, mechanical systems including HVAC (heating ventilation air conditioning) and refrigeration systems.
• Reviewed projects for compliance with standards from: USP chapter <797>, FDA & ADA, OSHA, and GMP Guidelines for manufacturing.