Resume of Kim Niles

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Career Summary

Certified Lean Six Sigma Master Black Belt and Quality professional with a Masters degree (MSQA) and over 18 years experience solving problems, developing new products, establishing standards, leading and managing people, and teaching topics of statistics, influencing people, creating change, and improvement.  American Society for Quality Fellow (top award). 

Summary of Quality Related Professional Accomplishments

·         R&D:  Axiomatic Design (science of design), TRIZ (structured creativity), DFX (feature pairing), Design for Six Sigma (DFSS), Risk Assessment, Experimental Design (DOE / EDX); Former VP for small prosthetics research acquired $100,000+ in NIH and LLNL medical grants.  One microwave food package patent application. 

·         Quality & Reliability Engineering: Certified Quality Engineer (12/7/2002 & updated in 2007 #44182).  Very experienced with tools such as FMEA, SQC/SPC, DOE, CpK; Personally solved problems up to $350,000,000 in value

·         Regulatory: Twice defended companies against the FDA.  One class action.   V&V’s, DOE’s, FMEA, HACCP, Adjunct for SDSU’s Bio-medical MS degree program.  Worked to/ established standards such as ISO14971, 13485, 9001:2000; TL16949; AS9000; QS9000

·         Statistics & Testing.  “outstanding statistician”; fluent Minitab and other stat s/w.  Have performed over 177 DOE's (Design of Experiments), 18+ Gage R&R's,V&V's (verification and validation), Time Series, Multivariable Analysis.  Modeling.  Automated testing (ATE).

·         Awards:  American Society for Quality Fellow 9/11/08.  Only one of 21 people in the USA in 2008 to receive this award.  Only a few people have ever received this award in San Diego.

·         Management: Director / Manager level up to 31 people; see linked-in recommendation “best Mgr. in SD” from past boss.  Ken Blanchard and Steven Covey enthusiast.  Strategic Plans/Models, Scorecards, Dashboards, Data Mining, Risk Analysis, Project Pick Lists.

·         Six Sigma/Lean: American Society for Quality (ASQ) certified Black Belt (#2740-10/16/2004 & updated 2007); UCSD certified Lean Six Sigma Master Black Belt; have taught 7 courses with ~70BB + several other courses of Green Belts (~95). Taught ~2600 students.       

·         Electronics:  SMT, Thru-hole, WaveSolder, AOI, PCBA, 30 units/ASE degree

·         Process Improvement: Stabilized 2.5 high vol. manuf. processes to >1.33 CpK

·         Cost Estimation:  Bus.Plans, Cash Flow, NPV, Cost est. & models; former Value Eng. 

·         Supply Chain Management: Gap Assessment, Audit,Qual,Eval., Teams, Stds.

·         Manuf.: “Lean Expert”, 5S, Flow, PokeYoke, SMED, TOC, VOC, VSM, Kaizen, 10waste

·         Machining: Managed Quality in 3+ machine shops; Hands on experience on CNC, mills, drills, gigs, sheet metal to 900T; Laser, arc, and MIG/TIG welding and cutting.

·         Material Science:  Thin-thick alloy; Phase diag.; Analytical techniques; Physics Optics

·         Multi-Industry:  Medical Device (all classes of devices, pharmaceutical and biologics); Semiconductor (wafer fab through test handling robotics); Automotive (TS16949); Aerospace (AS9100); Electronics (30units of basic circuit design); Software (SSQ)  

Main Work Related Experience

 

Alphatec Spine, Inc.  9/17/07 – 8/15/08 (~1yr).  Sr. QE.  SIC Code 3841 - Surgical and Medical Instruments and Apparatus.  Statistical and quality support for FDA 510K submissions, supply chain improvements, process validations, and up to 10 new product development teams for implant (screws, plates, rods, stints), instrument (surgical tools), and Biological development applications (stem cell, conditioned bone, pastes, packaging, etc.) for both MIS and traditional forms of surgery.  One DOE resulted in a discovery that moved development of an aspect of a novel Osteoporotic bone stint ahead by at least three months.  Provided statistical support for Stout Medical Group joint venture. 

 

Delta Design / Cohu  12/1/99 – 9/14/07 (8.75yr). QE then Quality Eng., Manager. Microchip test handling equipment (~$250MM/yr.; 1300empl.max). Implement statistical techniques & manage numerous special projects for Mfg., Eng., Littleton, Ohio, South Carolina, and parent Cohu. Dev. Quality systems, maintaining ISO, customer audits, internal audits, & Six Sigma. On 3 company purchase transition teams (Unisys, Kryotech, Slumberge).  DCCMM data mining and analysis. Cost analysis. Directly supervise to 18, Indirectly to 29.  Project Highlights: Significantly advanced dot code reading technology and resulted in developing a publication & new product for our sister company Cohu Electronics.  Braze weld projects TU's & laminates saved ~$400k/yr.  Four projects saved a customer sum total potential loss of ~$400MM/yr. via ESD & braze weld DOE's.  Chiller project for ~$2MM from ~90% to 5% reject rates. Internal trainer for Managers and Supervisors on quality tools and statistical techniques.  Internal facilitator of numerous Eng.& top management projects for barrier braking (bent lead at $4M).  Training: Cert. ISO Internal auditor, Relex, FMECA, FTA, Statistica, 8D, 7S, Six Sigma, TOPS, FLOW, Lean, JIT, Kanban, Value Stream Mapping, Time Mgment, and Interviewing.  5x Recipient of the prestigious Intel SCQA/PQS Awards (2000-2006)! 

 

1/4/99 – 11/29/99 Gap, See Consulting  / Contract Jobs Held, especially Alaris Medical.

 

Safeskin Corporation - Tactyl Technologies Division.  10/4/96-11/18/98.; Quality/Validation Engineer; then Process Engineer.  Natural & Synthetic Rubber Gloves, Condoms, Catheters, and Sleep Apnea Masks.  Responsible for all process improvement.  Assisted in attaining ISO9002 and CE mark (EN46002, MDD93-42-EEC).  Assisted cGMP then QSR compliance/CI efforts. V&V:IQ,OQ,PQ,PPQ and DOE: 60 screen, mixt., & Resp.surf. for QA, R&D, & Production problem solving.  Improved overall quality by 50% on one nine year old multimillion dollar production line saving ~$500,000/yr. (Forbes #1 American stock 10/96, #7 10/97).

 

Stillman Seal.  1/95-8/96.  Value Engineer.   Rubber, Metal, and Composite Seal and Dampener Manufacturing.

Responsible for all pricing and estimating requests for quotation (~40/day).  Project Engineer for all difficult projects. Performed 20 DOE's (Full, fractional, Taguchi, and Shanin) on two automotive processes saving potentially 4 million dollars per year.  Improved process quality from negative CpK to 1.43 using SPC & DoE’s.  Worked directly with France with work-cell re-org.  Wrote AR’s exceeding $100,000.  Company Safety Inspector.  Tooling Coordinator. 

 

Casio Manufacturing Corporation. 2/91-1/95. Engineer/QC Coordinator.  Consumer Electronics ($60MM).

Responsible for quality, delivery, and cost, from component suppliers and manufacturing at our Tijuana Maquiladora facility (piano keyboards & pocket TV's).  Supervisor for up to 15 receiving, source, and production QC inspectors.  ISO 9002 Project Manager.  Process engineering with injection molding (to 1950T), insert injection molding, gas assisted injection molding (GAIN), blow molding (to 20oz), preprint and corrugation, EPS/EPE foam molding, label manuf., electro-galvanizing, & metal stamping (to 900T). Japanese lang. proficiency of 30% , Spanish at 85%.

 

Deposition Technologies,Inc. 4/87-9/90. Application Engineer. Thin Film/Coating & Laminating.  New products and technical sales support.  Responsible for designing and specifying materials/processes utilizing the application of thin films & polymeric coatings through coating/laminating & vacuum metalizing technologies. Skin contact, atmospheric barrier, 1/4 wave multilayer optical designs, susceptor, and piezoelectric films.  Developed two joint ventures and five related patents.  One of my inventions generated $3 Million per year.  Pillsbury $300,000 negotiation.  Managed $400,000 lab equip. producing a profit center within R&D.   Eng.projects for all Material Science companies.

 

Biomagnetic Technologies, Inc. 9/85-3/87.  Research Technician II.  Manufacturing medical magnetic sensing equipment (Bio/Neuro-magnitometers).  Responsible for entire process of manufacturing and testing microchips, probe subassemblies, and final superconducting assemblies from complex blueprints.  Achieved an increase in chip yields per wafer of ~75%.  Designed a new chip checking procedure that allowed a 50% reduction in manpower.

 

Johnson & Johnson--The "A" Company. 1/84-9/85. Supervisor trainee and Engineering.  Orthodontics Mfg.

Setup of fourteen injection molding machines used in manufacturing precision orthodontic appliances.  Co-supervised twenty five (25) ethnically diverse employees.  Compiled statistical data and used mathematical models and interpolations to enhance production outputs and machine-mold yields.  Successfully increased production 12%.

 

Contract Jobs Held (explains gaps, no co-mingling)

 

  • Overland Storage: Fall 2008.  Green Belt training and coaching (18 students). Significant FPY improvement across all related products. One motor related DOE for noise reduction.  Estimated $500k saved from four teams.

  • SDSU MSBQA Program:  On-line class development through state grant entitled “Change and Improvement Management”.  First running was January 2008 which resulted in outstanding evaluation scores. 

  • UCSD Extension: 11/02 - present.  Co-taught 7 waves of Lean Six Sigma Black Belts and Six Sigma Black Belts.  Spring 2002 SSBB guest speaker. 

  • Ceranova Corporation - 1/94-8/97 (~3.5yr). Vice President; Co-wrote, received, and managed $80,000 SBIR grant for 25yr old 10 person medical prosthetic imaging Corp.  Led Lawrence Livermore National Lab team in STTR write up.  Patent work.

  • Business Process Solutions (BPS):  Taught several workshops and web updates. 

  • Global Quality Solutions (GQS):  Helped develop on-line training programs

  • General Atomics / Scharr  & Doublet II.  Consultant.  Doublet II and Successful deposition calculations of thin films for Desert Storm.  Contract project based jobs in 1990-1991; offered full time positions due to their success.

  • Synmeth Corporation Resin Transfer Molding Composite mold conversion.

  • Pacific Aerosystems, Inc.  Small contract job to build more robust military drones. 

  • Planet Polymer Technologies.  Biodegradable polymer.  Development work with owner.

  • Superconducting Quantum Magnetics (SQM), Physics research.  Co-wrote SBIR.  

 

Education 

 

  • Masters in Quality Science MSQA, June 2003. Cal State Dominguez Hills. 

  • Certified Six Sigma Master Black Belt. UCSD Extension May 31, 2006 

  • Bachelors in Industrial Technology, 1984. San Diego State University. 

  • Electronics Technology Mesa C.C. 1994 (Cert., A.S. Equivalent; 30units of electronics) 

  • Special Training: Numerous seminars and special training from related gurus. DOE training with Six Sigma originator, and author Keki Bhote. Statistics training with Stat Graphics founder Dr. Neil Pulhemous. DOE training with noted author Dr. Douglas Montgomery (also on SDSU advisory board together). TRIZ training (Russian acronym for theory of inventive problem solving) through UCSD's guru Dr. Ellen Domb.

   

Professional Societies, Organizations, & Affiliations

 

·     American Society for Quality (ASQ) Sect.703: ASQ Fellow 9/11/08;  Internet Liaison, newsletter editor, and historian.  Jan 2001 Six Sigma Conf.Org.Com. member.  Numerous talks & courses instructed. Sect.708: Finance & Plan.Com. 2000.  Taught 2 wrkshops 11/02 “Gage R&R & DOE”.  Gave talk on Change Management.  See talks.  

·     Palomar College Quality department advisory board member until 2005. (http://www.palomar.edu/vocationalprograms/QUALITY.html).

·     SDSU MSBQA.  MS in Bio-Medical Quality program advisory board member (http://interwork.sdsu.edu/cbbd/aboutus.htm) and class development.  

·     SDCEC/SDES - SD.Eng.Council was SD Eng.Soc.; Nat.Eng.Wk. 19+ San Diego orgs. Chaired Spec.Events, Pub.,web; Vice President for 10,500 members 1998 – 1999.

·     SAMPE - Soc.for the Adv.of Material & Process Eng.  2x Past Chair.  International Webmstr 1999-2000. ISSE45 Finance Chair / Process Sessions Chair, 3x speaker in Long Beach.  10,000 members, 105+ chapters 

      ·     SSQ - Soc.for Software Quality.  Member since 2008.

 ·    SPE - Vice President & Charter Mem. of Soc. of Plastics Eng. SDSU Chapter, 1984

·     Toastmasters – Chambers Toastmaster in Escondido.  CTM and web. 

·     UCSD Ext. Six Sigma program advisory board member (http://eng-ed.ucsd.edu/six-sigma.html) and adjunct instructor / Master Black Belt.  7 classes taught.   

 

Key Publications

 

·         Niles, Kim.  (May 27, 2002).  "Characterizing the Measurement Process". iSixSigma Insights.  Vol. 3, #42. Found at: http://www.iSixSigma.com/library/content/c020527a.asp

·         Niles, Kim.  (January 31, 2003).  "Six Sigma and Design of Experiments".  ASQ Six Sigma Forum - Master Black Belts.  Republished at: http://www.asqsandiego.org/articles/6s&doeimplementation.pdf

·         Niles, Kim.  (June 16, 2003).  "Most Practical DOE Explained (Includes Free Spreadsheet Template)".  iSixSigma Insights Newsletter.  Vol. 4, #45. ISSN: 1530-7603. Found at: http://www.isixsigma.com/library/content/c030616a.asp.

·         Niles, Kim.  (October 20, 2003).  "Process Improvement Prerequisites".  ASQ Six Sigma Forum.  Found at http://www.asqsandiego.org/articles/PIPrerequisites.pdf  

·         Niles, Kim. (September 19, 2004). “Importance of Test Plans/Test Protocol, with a Template". iSixSigma Insights. Ridgefield, CT. ISSN: 1530-7603. 375,000 circ. Found at: http://www.iSixSigma.com/library/content/c040920a.asp 

·         Niles, Kim.  (November 16, 2004).  "Experimental Test Strategy For Six Sigma Levels of Process Improvement".  The society for the advancement of Material and Process Engineering (SAMPE) international technical conference proceedings (ISTC 36). SAMPE. Covina, CA.   Re-published at: http://www.asqsandiego.org/articles/SPA_SAMPE_Pres2004_28.pdf

·         Many other publications, publications pending, and citations available upon request.

 

Speaking & Teaching Experience

See a list of 170 talks at http://members.cox.net/asqsd/kn/professional.htm#Speaking to local companies and organizations such as the American Society for Quality (ASQ703, 708, LA), the Society for Software Quality (SSQ), the Society for the Advancement of Materials and Process Engineers (SAMPE), the American Electronics Association (AeA), and many more.

References & Recommendations

See 8 referrals through my Linked-in profile at http://www.linkedin.com/in/kimniles

 

 

Last Update:   Sunday January 04, 2009