Engineer Medical
Resume:
Ming Ko
Email: *********@********.***
Address: ** ******
City: Newport Coast
State: CA
Zip: 92657
Country: USA
Phone: 408-***-****
Skill Level: Experienced
Salary Range: $90,000
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
Ming KO
56 Renata, Newport Coast,, CA 92657
Work/Cell: 408-***-****
*********@********.***
SUMMARY OF QUALIFICATIONS
Engineering, Quality and Regulatory Compliances experience in Class II and Class III medical devices industry.
Specialized in product R&D and manufacturing technologies. A hands-on manufacturing technologist with 8-year experience in medical devices.
Cleanrooms, cleaning and sterilization including: disinfection, sanitization, contamination control. Received corporate awards in developing and implementing bioburden control technology to enable to ship products just-in-time. Validation and cost-reduction of EO and gamma sterilization. Trained internal quality auditing teams. Proven track record in quality improvement, FMEA, yield enhancement, lean-six sigma, lean compliances, SPC, and project management.
Managed medical devices NPI, products transfer from site to site. Verification and Validation of manufacturing facilities due to plant consolidation and relocation between two sites in Arizona and California. GMP, QMS with compliances of FDA Quality System Regulation 21 CFR 820, AAMI/ISO in the key areas of medical devices manufacturing technologies.
Held key technology positions in high technology industries. Received and provided training in high tech industries and medical devices manufacturing and quality control of processes and materials. Submitted US patents in medical devices using innovative medical grades of polymers, metals, ceramics material and methods.
EXPERIENCE
Intuitive Surgical, Sunnyvale, CA March 2012 - Present
Manufacturing Engineering Consultant
aai Served as technical advisor in a aaiAimedical devices cleaning and sterilization technologyaaii
aai Led aaiAiSterilization Cost Reduction Teamaaii. Worked on aaiAiSix-Pallet Sterilization Chamber Validationaaii in parametric release, new packaging for EO Sterilization (with team members)
aai Conducted aaiAiCleanroom Management, Parts Cleaning and Cleanlinessaaii meetings
aai Developed a new cleanliness test of aaiAiParts Surface Particulate & Microbial Testingaaii. The Test Method was approved for implementation in order to monitor, identify root causes and to control product bioburden. This test method, if successfully implemented, will enable ISI to measure, monitor, control cleanliness of machine parts, components, and finished products with surface particulate measurement and microbial counts in a timely manner which is valuable to manufacturing process control of ISIaaiais da Vinci Surgical Systems disposable instrument products
aai Proposed a new aaiAiParts and Components Cleaning and Cleanliness Strategyaaii for in-house operation and suppliers.
aai Prepared and presented to management 4 presentations on aaiAiParts and Products Cleanliness and Bioburden. Issues and Solutionsaaii
aai Reviewed AAMI/ISO 11737, 11738, TIR 28:2009 on EO sterilization guidelines. Proposed new packaging design for better EO permeability and outgassing. Provided assistance to do foam bioburden testing, materials and processes of foam selection and testing. Contributed to add A inch hole to the white carton for better EO permeability
aai Support cleanroom protocol management and consumables. Worked on Cleanroom Cost Reduction plan.
aai Worked with team members and vendor CSI to validate CER and to perform quarterly CER monitoring. Provided technical support to Manufacturing, Janitorial Services and CSI cleanroom floor mat, non-contaminating cable protector, and consumables.
aai Gave presentations to management teams on:
o Cleanroom, Cleaning, Cleanliness Testing and Bioburden Control Technology
o Validation of Cleanroom Extension
o Medical Devices Parts and Components Cleaning and Cleanliness Testing
o Development of A New Cleanliness Testing: Surace Particulate and Microbial Testing
Endo Pharmaceuticals/American Medical Systems ( LASERSCOPE Corp.), San Jose, CA 2005-2011
Principal Engineer, R&D and Manufacturing Engineering, Supplier Quality Engineering, Laser Optics Products
aai Initiated and set-up microbiology lab for in-house microbiological testings. Received Bioburden Reduction Award
aai Proven tract-record of problem-solving of manufacturing issues relating to quality, yield, process control and reliability using innovative technologies of: polymers, ceramics and glasses, metals; methods of plating, metal finishes, adhesives, lubricants, gels, foams, coatings and films, surface treatments.
aai Conducted and performed Cleaning and Sterilization projects of disposable and re-usable optical fibers for prostate treatments: AAMI sterility validation, dose mapping and validation, biological indicator (BI) technologies, protocol generations, materials biocompatibility and selection, logistics and management of sterile loads. Trained and worked with ISO 11135, ISO 11737, ISO 11138, ISO 13485:2003 Class 3, AAMI/TIR 16-2000. Responsible for D value study, SAL validation, sterilization process validation, IQ, OQ, PQ, re-validation, BI improvements, use of PCD, standard validation (method C), parametric release, packing validation
aai Program coordinator of AMS-Phoenix plant closure and medical laser products (of BPH treatments) transfer to AMS-San Jose. Met US FDA/international regulatory compliances and completed Design History Files (DHF). Worked with a cross-functional team to complete the medical device product transfer. Completed transfer process validation, packaging validation (ISO 11607, related ASTM and ISTA standards), biocompatibility (ISO 10993), new class 10000 cleanroom validation (ISO 14644, ISO 14698), sterilization re-validation (ISO 11135, ISO 11737, ISO 11138, related AAMI standards). Passed the corporate audit and BSI audit with signed off upon program completion.
aai Implemented world class manufacturing to comply with Good Manufacturing Practices.
aai Led, planned, organized, implemented contamination control, cleaning and cleanliness related projects in all phases of new product development and introduction: design review, materials selection of optics/components/hardwares.
aai Conducted periodic supplier quality audits and manufacturing improvements at Gooch & Housego (U.K.), Mitsubishi (Japan), JDS Uniphase (China) and 12 out-of-state suppliers in U.S.
aai Set up and implemented corporate cleaning and cleanliness strategy for in-house and supply chains management. Authored cleanroom protocol. Implemented world class manufacturing to comply with Good Manufacturing Practices and 5S.
aai Completed a dozen of training programs in the key areas of: Quality and Regulatory Compliances by American Society of Quality (ASQ), Six sigma program by ASQ, Science of Sterilization Validation by Nelson Laboratories
aai Trained and implemented Six Sigma, 5S World Class Manufacturing, BSI audits, cycle time reduction, concurrent engineering, supplier quality engineering
aai Filed 5 patents of medical devices relating to using new design, innovative processes and novel materials of laser-resistant polymers, inorganics,and metals
aai Gave seminars of various topics:
o Cleaning and sterilization validation protocol for reusable and medical devices per AAMI TIR30-2003
o Cleaning and Sterilization Validation Protocol for Reusable & Dispoable Medical Devices (AAMI TIR30-2003 review)
o Medical Devices Cleanroom Protocol and Training
MICRO LITHOGRAPHY, INC., Sunnyvale, CA 2004-2005
Engineering Manager, Photolithography Cleaning Technology
Worked for worldaaiais major manufacturing of DUV (for Excimer lasers) pellicles for photomasks used in semiconductor integrated circuits production. Reduced particulate and organic contamination defects 2 logs levels. Provided world-wide needs for Class 1 cleanliness photomask pellicles to manufacture 4-Gb memory chips using DUV sub 0.2 um features and beyond.
aai Led technical and engineering teams to resolve yield and quality issues. Reduced particulate contamination on pellicle surface 50%. Decreased coating and film defects 25%. Increased pellicle frames yield 30%. Renovated Cleanrooms from Class 100 to Class 1.
aai Supervised a cleaning and anodizing laboratory. Set up a new wet lab and testing lab. Developed new cleaning and etching processes for R&D and manufacturing.
JDS UNIPHASE/SDL, San Jose, CA 2001-2004
Manufacturing Engineering Manager, Corporate ESD and Contamination Control Engineer
Experienced in manufacturing yield improvement strategies.
aai Managed teams to transfer technologies from New Jersey and Holland sites for front-end and back-end manufacturing lines making optoelectronic components and subsystems of sensors, laser diodes, 980, DWDM and 20 photonics products. High power laser diode manufacturing engineering changes to improve product yield and reliability.
aai Developed and improved various processes: cleaning, Cleanroom, ESD, chemical etch, electrochemical process and plating, contamination control; molecular contamination, outgassing, ionics and corrosion, particulate reduction.
APPLIED MATERIALS/AKT, Santa Clara, CA 1999-2001
Senior Member of Technical Staff, Flat Panel Displays and CMP Divisions
aai Set up materials and contamination / ESD lab and develop propriety processes for improving PECVD TFT-LCD manufacturing
aai Developed key processes to improve final clean of oxide and copper CMP process for 300 mm wafer manufacturing of 0.1 um technology in Class 1 cleanroom environment.
aai Knowledge and experience in metal and non-metal surface finishes; polymers, metals, alloys, ceramics, adhesives, soldering, coatings, thin-films, thick films, metal finishes, platings, polishing, etch, chemical treatments.
WESTERN DIGITAL CORP. San Jose, CA 1997-1999
Senior Staff Engineer and Manager
Worked in materials integration and process development using innovative technologies: polishing, cleaning, etching, burnish, buff to make high performance high volume production of magnetic disks and disk-drives.
KOMAG, San Jose, CA 1993-1997
Principal Engineer
aai Developed new cleaning processes. Contributed to implementation of new improved final etch, electroless plating, polishing and texturing lubricants for giant magnetoresistive (GMR) disk products. Improved final production yield from 80% to 92%.
IBM, San Jose, CA 1980-1993
Advisory Engineer
aai Worked in IBM slider fabrication, wafer fab, HGA, HSA, magnetic media, HDD on process control, monitoring and process improvement. Wet-chemistry etch, reactive ion etch (RIE) to achieve etch uniformity, etch selectivity and low defects. The proprietary aaiAiADTaaii process has still been in use to produce the most advanced giant magneto-resistive (GMR) heads. Applied focal ultrasonic dispersion for 0.2 um diamond polishing slurry. Implemented CO2 snow clean and laser cleaning for PVD and CVD tools and parts. Used UV/ozone clean to improve thin film adhesion properties for magnetic sliders.
aai Received IBM corporate and division awards, wrote book chapters, published papers and patents
EDUCATION
Ph.D. Organic and Biochemistry, Georgia Institute of Technology, Atlanta, GA
B.S. in Biochemistry, National Taiwan University, Taipei, Taiwan
MBA, Technology Management, Golden Gate University, San Francisco, CA
AWARDS
aai IBM Outstanding Achievement Award
aai IBM Corporate Technical Excellence Award
aai 2 AMS Corporate Awards and 5 US Patents
aai IBM Corporate Outstanding Technical Achievement Award
aai IBM Invention Achievement Award
aai 1 Intuitive Surgicasl US patent application
PUBLICATIONS, PRESENTATIONS, TEACHING TUTORIALS
aai Presented more than 30 presentations, papers in the areas of cleaning technology and contamination control
aai Earned 17 IBM invention points. 5 US patents in medical laser devices
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