Engineer Quality

PETER TRAN

***** ******** **, ****# *** Primary contact: Cell Phone: (858) 617- 9125.

San Diego, CA 92131 Secondary contact: Home Phone: 858-***-****

Email: ac0tbe@r.postjobfree.com

OBJECTIVE: Sr. Quality Engineer, SQE

SUMMARY

Provided support for OMNITRACS/Qualcomm MAS110/200 and Trailer-Trax, TT210 product line. Provided detailed and comprehensive bi-weekly and monthly yield reports. Reviewed Gauge R&R and Ppk reports and performed GR&R Failures Analysis by applying the Minitab Glove Quality Tool Results to reduce RMAs and continually improve Quality and Product Reliability on MAS Products and internal test equipment and test equipment used by the contract manufactures (CM’s) for pre-functional and functional test. Worked extensively with CM’s both domestically and internationally (Malaysia) to improve quality yields.

Result: Closed out legacy manufacturing non-compliances and increased supplier rating from 74% to 97% in two months.

Summary working without appreciable supervision provides technical expertise and guidance to the functional areas of Returned Device Product Analyses and Testing. Serve as primary technical representative for failure analysis for corrective action (CAPA) 21 CFR 820.100 and actuarial reliability analysis for Product Performance reporting for implantable medical devices according to ISO 14971 and ISO 13485.

Works with R&D, Manufacturing, Legal, and Technical Services on reliability improvement efforts [ESS, HALT, HASS, RDT, Reliability testing, MIL-STD-781. MIL-STD-785, MIL-STD-2164] and risk management activities for application providers in a variety of market segments such as data and telecommunications, automation, mobile computing, medical technology, military technology, aerospace, and measuring and control engineering.

Supplies useful data for improving product reliability, Customer support and defending legal cases. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation by stress analysis, parts stress analysis, fatigue life analysis, derating analysis, or worst case analysis and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective. Cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.

ACCOMPLISHMENTS

KONTRON AMERICA INC.,

• These are the key concepts that have helped to make Kontron one of the world’s leading suppliers of embedded computer technology. Founded in 1962 and headquartered in Germany, we design and manufacture standard-based and custom embedded and communication solutions for OEMs, systems integrators, and application providers in a variety of market segments such as data and telecommunications, automation, mobile computing, medical technology, military technology, aerospace, and measuring and control engineering.

B. BRAUN MEDICAL INC.,

• Develops, implements and oversees complex quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, PDCA and analyses for IV Solution Products (e. g: Glass, PAB, Duplex, Excel). Ensures that performance and product quality conforms to established company, customer and regulatory requirements. Reviews, analyzes and reports on quality discrepancies related to complex assemblies and processes. Leads investigation complex problems and develops dispositions, modifications and corrective actions for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, and vendor and subcontractor representatives to ensure requirements are met.

CARDINAL HEALTH INC.,

• Developed and implemented a system to track, trends, and reports out of box product performance.

• Successfully completed a project to work with the Service Depot and Product Focus Teams to implement better focused and detailed reporting of service repairs to the root cause component/failure.

• Developed and implemented a system to track, trends, and report product manufacturing and field service data used by the Product Focus Team to determine CAPA 21 CFR 820.100 and project initiation.

• Implemented a SPC tool to track, trends and report first year field service repair results.

• Utilized Reliability Engineering Tools (Warranty Analysis and Weibull ++ Analysis) to analyze service data for tracking and predicting field corrective action progress and product/component failure performance.

PROFESSIONAL EXPERIENCE

KONTRON AMERICA INC., Poway, CA 2011-Present

• Manufacturing environment one of the world’s leading suppliers of embedded computer technology. Kontron designs and manufacture standard-based and custom embedded and communication solutions for OEMs, systems integrators, and application providers in a variety of market segments such as data and telecommunications, automation, mobile computing, medical technology, military technology, aerospace, and measuring and control engineering. Providing the quality assurance support necessary to ensure that purchased parts and manufactured goods conform to company standards for design, procurement, manufacture and reliability.

Sr. Quality/Reliability Engineer

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

• Ability to develop reliability testing and create reports such as HALT&HASS, ORT, RDT

• Ability to develop quality plan, testing and create report that including Gage R&R, Cpk, Ppk, MTBF, FMEA, FPY, Control Plans, etc.

• Ability to develop WI work instructions and test procedures.

• Ability to reviewing analyze of dFMEA, pFMEA, DFM, DFT, DFA (Design for Manufacturability- Test -and Assembly).

• Ability to develop Reliability Analysis on the life cycle of product and identify failure analysis, to understand the overall quality and product reliability.

• Ability to manage the statistical analysis on products to determine the patterns seen and unseen providing insight to the lifecycle of the product.

• Ability to develop Quality Plans setting expectations during early stages of customer relationships.

• Ability to use measurement & inspection tools and equipment such as Flukes, Calipers, Granite Table, Micrometers, Thread Gauges, Pin Gauges, etc.

• Knowledgeable of IPC-A-610 & IPC-WHMA-620. ICS Certification is a plus.

• Six Sigma & Lean Manufacturing application 5S, 5Y, 5 Why, SMED, JIT, TQM, PDCA, DOE, Kaizen, process map, flow, Kanban, DMAIC, TAKT, Poka Yoke.

• Oversees the development, modification, and maintenance of quality evaluation, control plans and protocols for processing materials into partially finished or finished products.

• Oversees the development and implementation of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

• Responsible for Corrective and Preventive Action (CAPA) Program, NCMR System.

• Expertise on Process validation (IQ/OQ/PQ) for hardware/software integration test by using evaluation prototype i.e. white/black boxes test, compiler, source codes, etc.

• Oversees the auditing of quality systems for deficiency identification and correction.

Oversees the process for ensuring that corrective measures meet acceptable reliability standards and that documentation is complete and compliant with requirements.

B. BRAUN MEDICAL INC., Irvine, CA 2009-2011

Manufacturing environment for Pharmaceutical including intravenous B BRAUN Infusion Pumps, IV Solutions: Glass, PAB, Duplex and Excel.

Sr. Quality Engineer

• Oversees the development, modification, and maintenance of quality evaluation, control plans and protocols for processing materials into partially finished or finished products.

• Oversees the development and implementation of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

• Oversees the design and analysis of inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine responsibility for, products or materials that do not meet required standards and specifications.

• Responsible for Corrective and Preventive Action (CAPA) Program, NCMR System.

• Hands-on SPC, design of experiments, risk management, FMEA (use design and process), statistical sampling techniques by, using statistical software such as Minitab or ReliaSoft, Weibull++.

• Expertise on Process validation (IQ/OQ/PQ), test method validation, Gage R&R, etc.

• Oversees the auditing of quality systems for deficiency identification and correction.

• Oversees the process for ensuring that corrective measures meet acceptable reliability standards and that documentation is complete and compliant with requirements.

• Specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

• Provides direction and mentoring to less experience QA/QE Engineers.

CARDINAL HEALTH INC., San Diego, CA 2002-2009

Manufacturing environment for medical devices including intravenous ALARIS Infusion Pumps, SpO2, EtCO2 Modules, Nightingale and RFID Medication Station Systems.

Sr. Reliability Engineer

• Assigned to a Product Focus Team as the Product Reliability Engineer. Responsible for providing quality engineering and technical support for product sustaining activities and resolving problems in the manufacturing process, procured material quality, and product quality/reliability. Additional responsibilities include working with other functional groups including product design, service depot, customer advocacy, clinical and product safety/regulatory. Created quality verification tests plan for environmental testing that included thermal, HALT, HASS, ESS, RDT, Shock, Vibration, and Drop testing.

• Developed temperature and humidity test profiles and programmed it into environmental test chamber.

• Performed quality verification testing using environmental test chamber and created test reports.

• Reviewed test results/data from external lab environmental testing.

• Search and make decision to purchase capital equipment to setup the Reliability Engineering Lab, which is used to evaluate non-conformance parts from Manufacturing and fields returned.

• Performed in depth Fault Tree Analysis (FTA) and FMECA to identify the root cause, and make appropriate corrective actions to improve the product reliability. The specific action related to correction of a non-conformity and prevention of further non-conformance occurrence (CAPA).

ALARIS MEDICAL SYSTEMS INC., San Diego, CA 1998-2002

Manufacturing environment for medical devices including intravenous ALARIS Infusion Pumps and MEDLEY patient monitoring systems.

Test Engineer

• Assisted in the design, development and evaluation of new circuits and systems.

• Designed, layout, and built prototype circuits and test fixtures.

• Troubleshooting and repaired circuits and fixtures with expertise in the use of electronics equipment such as Oscilloscopes, Logic Analyzers, DVM’s, Spectrum Analyzers, etc.

• Documented all activities from schematic capture to test results.

• Complied with department and corporate procedures and quality initiatives

• Worked closely with Manufacturing Engineering, R&D Engineering. Supplier Engineering and Quality Engineering to understand product performance, and reliability issues.

• Performed on-going engineering support of existing products including redesign and/or modification to resolve product design issues.

• Conducted and document product design verification. Installation and operation qualification such as IQ, OQ, PQ, PPE, EPQ, & MVP to support Production Lines and Production Test Lab (PTL).

• Tested new product designs and feedback test results aiming at the quality systems compliance.

• Performed finished product document review and release.

• Developed and implement test cases, test plan and protocols of complex infusion pump systems and associated product such as Heart Card, Life Signs, Cardiac Memo, King of Heart, etc…

• Defined project timeline for test development including planning, balance resources, evaluate process, analyze budge, and coordinate the design & implementation of software & hardware.

NELLCOR PURITANT BENNETT INC., Carlsbad, CA 1991-1998

Manufacturing environment for medical devices including patient monitoring systems, oxygen sensor and ventilators.

Failure Analysis Engineer

• Evaluated product specifications for development of environmental testing plan.

• Analytical, simulation capabilities with Instrument circuits, Biomedical devices circuits as Pulse

• Oximetry/Gas product.

• Established, supervised, and maintained product quality systems, audit activities, and testing development.

• Interfaced with product design/development and manufacturing functions.

• Performed statistical data analysis – process capability (Cr,Cp and Cpk).

• Prepared control plans, process maps, cause and effect matrix, and failure mode effects analysis (FMEA).

• Participated in product failure analysis and maintained closed loop corrective action and prevention systems (CAPA).

• Established and implemented manufacturing process data reporting/SPC systems.

• Prepared and maintained departmental and ISO 9000 documentation.

LELAND VIDEO GAMES CORP., El Cajon, CA 1989-1991

Product and manufacturing development environment for video games, and other miscellaneous products.

Associate Engineer

• Assist Project Engineering in designing and developing prototype and test fixtures, evaluation, design quality assurance, product safety and regulatory compliance, supplier quality engineering (part quality assurance, receiving inspection, material review board).

• Designed Analog/Digital Filters (IIR.FIR), and A/D.D/A conversion techniques.

• Troubleshooting in Microprocessor based systems (8085/8088/80186), and servicing on all Consumers products in electronics as Receivers &Transmitters and Television Set.

• Knowledge with PC hardware/software interface and UNIX platform.

• Developed practical troubleshooting technique and training for field service technicians.

• Successfully improved the quality level at product release by pushing problem discovery/resolution upstream, advocating continuous improvement, and promoting “ do it right the first time” objectives.

EDUCATION AND TRAINING

• Attended School of Six Sigma and has completed 53 hours of video and all quizzes as required for Six Sigma BB certified.

• Attended Public Minitab for Glove Quality Analysis Results

• Attended Refresher CQE Course for reducing the Cost of Quality.

• Reliability Engineering (Various ReliaSoft’s Reliability seminar. Course RS560 on the subject of introduction to Design for Reliability, (ASQ)

• In recognition of having attended an education program on the subject of Principle Failure Analysis, HELLIER ASS, CONNECTICUT.

• In recognition of having attended an education program on the subject of Creative Problem Solving and Facilitation Skill, UCSD Extension.

• In recognition of having attended an education program on the subject of Statistical Process Control (SPC).

• FDA Good Manufacturing Practices (G.M.P & ISO 9000, 9001, 9002, 9003 and 9004), University of California San Diego UCSD Extension.

• Electrical Engineering (BSEE) USC

• Electronics Engineering (AAS) SCC

• Journeyman Specialties in Consumer, Registration # CA2271, ISCET

• Certified Telex-Com Engineer, CTE Class III, NARTE.

PROFESSIONAL CERTIFICATION AND AFFILIATIONS

• Society of Reliability Engineers (SRE) Membership.

• American Society for Quality (ASQ) Membership.

• National Association of Radio & Telex Communication Engineers (NARTE) Membership.

• International Society of Certified Electronics Technicians (ISCET) Membership.

REFERENCES

Available per request

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