1. JESUS ARNOLDO CASTRO
10294 Eagle Rock Ave., San Diego, CA 92126
Cel: (858) 527-2571, H: (858)564-8618, arnoldqubo@gmail.com
OBJECTIVE
Position in a company of high technology products, where my skills and background in
manufacturing directly impacts a company’s excellence – SeniorStaffManufacturingor
Mechanical Engineer.
Education
BS in ElectromechanicalEngineering, Mechanical Engineering specialization.
UABC University 1979 – 1987
U. S. Citizen.
Bilingual (English/Spanish)
Six Sigma BlackBelt, certificateof completion (Mansfield, MA USA. Year 2002).
Certified Validation Practitioner (Sandy, UTUSA).
Planing and Leading Projects– BD University (San Diego, CA)
SUMMARYOF QUALIFICATIONS
*Six Sigma Methodologies. Proficientin process capabilities studies, design of experiments
(DOE),FMEA,and SPC.
*Manufacturing engineering experience formedical products. FDA regulations, ISO
9001:2000/2008, ISO 13485.
*Proficientin process validations (Development,IQ, OQ,PQ).Communication skills, written and
oral.
*6 years Quality Assurance backgroung. ISO implementation and sustaing; ISO representative.
Quality auditor, CAPA responding to internal and external customer non-conformances.
*Signinfican amount of research workand development for product design improvements (e. g.:
new materials, design features), process changes, and new technology.Examples: use of 6-axis
robots automation, new IC catheter implementation, convertionof gum silicone process to LIM.
*Significant involvementin mold designs and mold qualifications for thermoplastics and
thermosets (silicones).
*10 years experience in medical products manufacturing, assembly and molding operations;
including injection of thermoplastics, LIM, transfer/compression silicone rubbers.
*3 years hands on engineering experience: blood collectiondevices; UV cured bonding, silicone
adhesive bonding.
*3 years on extrusion processing. PP,PE,and silicone materials. Medical products (PP
corrugated tube, PE catheters tubing, angioplasty catheter tubing, 1-3 lumens silicone shafts for
Foley catheters, silicone thoracic cathethers).

2. ACCOMPLISHMENTS(frommostrecent)
*Implementation of three manufacturing cells that included IML injection molding and 6-axis
robots. Cycle time improvement from 35 seconds budget to 23.5 seconds. It represents 60%
company’s revenue.
*Designed and construction of cutting dies, thermoforming tools, injection molds design
modifications at Canyon Graphics using SolidWorks. Saving $50K in capital and $40K per year in
production.
*Trnasfered the medical sharps collectorsmanufacturing processes from Oceanside, CA to
Juarez, Mexico. Providedthe validation training, supporting the process development, reviewing
and approving validation protocols and reports.
*Reduced failures and increased productivity on 1 lt. sharp collectorwitha costimprovement of
$145K.
*Implement SPC on twomolded parts (1074/1075) using molding machine software.
*Led and mentored site validation effectiveness, achieving high level of performance according
to corporate indicators.
*Completed Six Sigma Black Belt training and projects implementation to save $200K.
*Re-designed the silicone catheter balloons to resolve quality issues. Molds design
modifications, new molds construction,and molding process improvements using FMEA and
DOE's.Validations completed forthe design changes.
*Developed the manufacturing process and design modifications for a new infectioncontrol
Foley catheter. Validate extrusion process, injection molding and assembly for this productin
different French sizes.
*Converted a transfer silicone process to liquid injection for a mediastinal catheter. Cost
reduction in material and labor, $30K/year.
*Transferred of a disposable brain surgery kit manufacturing from Boulder, Colorado to Mexico.
Implementation of the assembly operation and development of the extrusion process to produce
a 3-lumen silicone tubes.
*Designed 1,000/100,000 class clean rooms. Including 340 tons air conditioning system.
EMPLOYMENT HISTORY
Staff SeniorManufacturing Engineer
ACCRIVA DIAGNOSTICS
Sep.8, 2014 - Present|San Diego,CA
Overseesexternal moldingsuppliers;over100 Accriva'stools(componentsforinstrumens,disosable
incisiondevicesandcuvettesforbloodcoagulationtesting).Reviewing/approvingvalidation
protocols/reports.WrittenEngineeringStudiesProtocolsforfinishedproductevaluations(incision
devices,instruments,cuvettesfor bloodcoagulationtesting) tosupportcomponentchanges;
updatngpart drawingsandSOP's.Newmoldsprocurement;revisedquotes,moldsdesigns,and
construction.InteractintwithR&DandMarketing.
QualityAssuranceMgr./ProductionMgr.
CANYON GRAPHICS CORP.
July 2010 – August 22, 2014 | San Diego, CA

3. Canyon produces IML/IMD(In mold label/decoration) using molding machines, and robotic (6
axis) automation; silk screen printing process forindustrial applications; laser/digital knife
cutting; and others.
Oversees Quality Management System; interfaced with customers; updating to ISO9001:2008.
Oversees production and providing specialized engineering support.q
Staff ManufacturingEngineer/SiteValidationLeader
BD MEDICAL
January 2008 – June 2010 | Oceanside, CA
Supported and lead process improvements, molds modifications,and process changes using a
Six Sigma approach. Performed process developments using scientific/decoupled techniques
and DOE studies; writing validation protocols, conducting all validation activities, and final
reports. Validation leader to improve the site validation effectiveness,based on a corporate
initiative.
Production/QAManager,MoldingProcessEngineer
ENSTROMMOLD AND ENGINEERINGINC.
January 2003 – December 2007 | San Marcos, CA USA
Company dedicated to plastic injection mold design, molds construction,production of plastic
parts, and assembly. Medical devices, water management, blinds, and others.
Started as a ProductionMgr. and hands-on support to improve the injection molding processes.
Later the QA position was added to my responsibility.
SeniorManufacturingEngineer
TYCOHEALTHCARE - KENDALL/SHERWOOD/MALLINCKRODT
December 1998 – October 2002
Engineering support, manufacturing processes, documentation, leading projects, R&D activities,
and validations. Silicone catheters and disposable blood collectiondevices manufacturing areas;
assembly operations; silicone injection/transfer/compression molding and extrusion processes.
Six Sigma approach engineering studies. Quality team leader to coordinate correctiveactions to
resolve customer complaints, FDA, or ISO/ENauditor’s observations. Interfacing with external
vendors, suppliers and R&D. New product transfer coordinator.
Molding/ExtrusionSeniorManufacturingEngineer
KENDALLHEALTHCARE
November 1996 – November 1998
Process and project engineering for the molding and extrusion areas. 51 injection molding
machines, 11 extruders, and auxiliary equipment for the manufacturing of medical products.
Equipment investments and implementation. Molds construction projects lead. Process
validations. Interfacing with external vendors, suppliers and R&D.
Molding/AssemblyProductionManager
InjectionMoldingEngineer
PLASTICUSS. A. DE C. V.
1988 – 1996

4. Productionmanager of the molding and assembly areas for professional videocassettes under
clean room environment.
Plastic injection process and assembly of high precision parts such as medical devices(including
angioplasty catheters). Clean room environments 1,000/100,000 class. 216 workersunder my
command.
Process set-up for new molds, resolve parts quality issues, molding machines and auxiliary
equipment maintenance. Supervised internal mold maintenance.
ComputerSkills
MS OfficePro,MS Project,MiniTab for statistical analysis, Documentum/SAP/JDE for
documentation and BOM’S, Trackwise forNC's, Solid Works, CorelDraw.