Manufacturing Manager Engineer
Resume:
Eng. Victor Ortega Martínez
P R I N C I P A L M A N U F A C T U R I N G E N G I N E E R
SUMMARY
admwgb@r.postjobfree.com
Results-oriented professional with over 15 years of successful and highly progressive manufacturing operations experience within worldwide companies. Extensive experience in healthcare and medical device industries. I specialize in working with multi-functional groups, I have the focus on validation processes including the development of processes by scientific molding. Passionate about managing staff and sharing knowledge.
CORE COMPETENCIES
• Process Control (CPK) • Product Engineering • Product & Project Management
• Certified ISO 9000 Auditor • CIM, SAP, E1, Mainframe Systems • Six Sigma & Lean Manufacturing
• ISO Procedures & Programs • Technical Support for Installations
• Molding Process Development
Decoupling Molding
• Extrusion, Injection Molding
(RIM and LIM), Powder
Coating, Carbon Fiber Braces
• Molding & Manufacturing • Packaging, Specs, BOMs & Costing • Wires: Braiding Process
• R&D: Adhesive Alternatives • Standard Cost Product Calculations • Team Management
• Preventive Maintenance
Schedules
• PVC, HDPE, Polycarbonate, ABS,
EVA,
Acetyl, Acrylic, Polyolefin & Silicone
• Troubleshooting Processes &
Validations
• Packaging stability
Validations
• Biocompatibility Studies • Injection machine selection and Purchasing
PROFESSIONAL EXPERIENCE
Molding and Extrusion Principal Engineer at Cardinal Health 2012 - 2020 The company provides clinically-proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Responsible for the validation processes of the molding area, transfer molds or new molds, following the procedures of the company, interacting with the operational areas, providing technical support, also actively worked at the implementation of new resins. Later I got promoted as Discontinuation Supervisor having the main focus of maintaining services.
• Validations: Validate new or material changes, Decoupling molding validations, cost reduction initiatives.
• Operations: Engineering Support molding operation 60 mold machines and 7 extrusion machines.
• Projects: Manufacturing Engineer in molded projects (New Molds, Resin Changes, New machines) Achievements:
• In the last Year, four resin Change for Opex project were validated 8 molds, plus Kresin Change for high runner’s products plus Business continuation.
• In the last two Years validate two discontinued Polypropylene Resin high volume 24 molds involved. Manufacturing Engineer (Business Leader) at Ossur Mexico 2011 - 2012 As a leading non-invasive orthopedic company, we provide advanced and innovative technology in the fields of prosthetics, orthotics, and compression therapy.
• Transfers: Spearhead the transfer of Foothill Ranch CA Foam molding facility to Tijuana, MX. Business lead: Foot Cover operations (Reaction Injection Molding). Achievements:
• Transferred RIM processes from Foot Hill Ranch, CA. and run Business unit Product Engineering Manager at Carefusion (currently DB) 2007 - 2011 The company provides clinically-proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home.
• Operations: Managed 51 molds, created new models, spearheaded engineering of international and domestic product relabeling initiative, NPI for IV sets and developed strategic packaging.
• Team Management: Managed 14 Product Engineers and 2 supervisors.
• Manufacturing: Coordination of new molds Built including (mold and component validation). Documentation: Created SOPs, BOMs, Routing, Validation Protocols, Deviations, ECOs, Red Lines, SWIs, CAPAs, SRDs, CAR (Capital Appropriation Request), 21CFR-820, EN980, ISO 13485, ISO 14000. Achievements:
• Led strategic packaging project, saving $3M in material and sizing changes.
• Instituted mold configuration and cavity increase project, saving $700K.
• Developed more than 140 new IV set models in last 3-years. (2010 sales $31M).
• Built 8 molds and refurbished 5 molds. (including validation and verification)
• Developed 51 new IV set models per year. (2007 sales: $10M 3-year goal through 2010: $31M) Manufacturing Manager at Avail Medical (currently Flex) 2004 - 2007
• Operations: Trained for 3 weeks in Ireland and Boston, MA on operations and processes. Team Management: Managed 9 Manufacturing Engineers.
• Manufacturing: Part of the Transfer team operation from Ireland and Boston, MA.
• Documentation: Created MAPs, BOMs, Routing, Validation Protocols, Deviations, ECOs, and Red Lines.
Achievements:
• Transferred grinding and assembly processes from Boston, MA. Transferred molding and pick and place production lines from Ireland. Engineering Sustaining for transferred operation. Molding Manager at Westmed 2002 - 2004
Develop, manufacture and market anesthesia and respiratory disposable medical devices
• Transfers: Trained for 3 weeks in Tucson, AZ in extrusion operations and worked with transfer team. Team Management: Managed a 2-shift molding operation with 4 supervisors and 100 direct reports.
• Operations: Maintained Extruders, Dipping, Insert, Blow and Roto Molders, Ultrasonic welders and FFS operations.
• Documentation: Oversaw creation of validation protocols and process instructions. Achievements:
• Assumed and ran Roto and Blow Molding processes without formal training.
• Transferred 2 extrusion lines from Tucson, AZ.
Product Engineering Manager at Raychem (Tyco Adhesives) 1983 - 2001 An industrial company supporting Oil industry.
KEY CERTIFICATIONS:
Management, Process, and Technical Training/Proficiency: Six Sigma/Lean Manufacturing: Thorough knowledge of Kaizen, Shainin and DOE, Kanban, MRP, Lean Manufacturing, Cellular Manufacturing, JIT, 5S’s+S, Visual Factory, SPC, SMED, CPK analysis, QFD, Outsourcing, Poka-Yoke, PDCA, DMAIC, TPM, MRP-II, and systems implementation.
Plastics, Flexible PVC and Silicone: Extrusion, Expansion: Injection, Dipping, Insert, Blow, Roto, Transfer, RIM, LIM and Thermoforming Molding, Slitting, Coating, Bond products, Cutting, Printing, Corrugation, Co-extrusion, Stripe, Milling, Die cut, Ultrasonic Welder, Pick and Place, and Grinding (industrial & medical), Powder Coating, Fiber Carbon Braces. Assembly: Heaters modules for trains, manual syringe assembly, respiratory products, IV sets, Introducers, and Diagnostic Catheters.
Packaging: FFS, Uranias, conveyors, Autobag, Flow Wrap and box sealers. Main frames: AS400, MAPICS, AMAPS, MAXCIM, ROSES, PIP, SAP, BPCS, CIM, and M2M. Executive Training:
Master Molder I Certificate at RJG, INC. 2018 Woodstock, GA (Two Weeks) Manufacturing Operation at Foothills Ranch, CA (Five months) Systematic molding Training at RJG, INC. 2010 Tijuana, MX (24 hrs.) Green Belt Training at Cardinal Health, 2009 Tijuana, MX (80 hrs.) Systematic Molding for Mold Builders and Tooling Engineers at RJG, INC. 2008, Riverside
(24 hrs.)
Diplomado en Plasticos at CIQA, 2008, Tijuana, MX (40 hrs.) Supervision Efectiva at Chavarin Velazco Consultores (24 hrs.) Sterilization of Medical Devices at Steris, 2008, Tijuana, MX (4 hrs.) Process Validation at Evolucion, 2007, Tijuana, MX (24 hrs.) CQE Course at ASQ, 2004, Tijuana, MX (63 hrs.)
AutoCAD 2000 at Computraining Autodesk, 2000, Tijuana, MX (50 hrs.) Lean Manufacturing at Raychem, 2001, Tijuana, MX
Diplomado de Hidráulica at Tec. de Tijuana y FESTO 1998, Tijuana, MX (120 hrs.) SMED at Raychem, 2000, Tijuana, MX
EDUCATION
// Master in Business Administration
Escuela del Pacífico 2001 - 2002
// Bachelor Degree in Industrial Engineering
Instituto Politécnico Nacional 1979 - 1983
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