Industrial Engineer Manufacturing Process
Resume:
René Morones
**********@*****.***
Mobile: 619-***-****
San Diego, CA
SUMMARY
Bilingual (English 95% / Native Spanish), Degreed Industrial Engineer with 26 years of experience on manufacturing process (Sustaining and Launching “NPD, NPI”) of:
- Medical products (low and high-volume) Involved with Clean Room environment compliance, GMP’s, QSR and ISO13485, ISO14971.
- HLA (High level Assembly “Electronic devices”).
- Injection Molding (Injection Machines and molding tools validation, Coordination purchasing and design of new molding tools, refurbish reparation, process transference, measurement process verification GR&R, etc.)
• Excellent leadership, motivation, and people skills.
• Ability to analyze existing methods and improve upon.
• Strong process engineering techniques and Q.C
• Strong equipment and Process Validation understanding (Including Molding tools, Injection Machines, and sterilization)
• Excellent problem solving, planning, and budgeting skills.
• Accountable for the operational and financial performance of assigned accounts.
• Strong Financial and analytical ability (forecast development, budgetary, P&L, Variance reports, monitor cost and cost trends “to improve value”).
• Experienced with the use of JIT, Six Sigma and Lean methodologies.
• Proficiency in use of personal computers, Microsoft Office products (Excel, Word, PowerPoint “Internal and External presentations”), TM1 “Business Performance Review”, Minitab “Statistical reports and data analysis”, ServiceNow “Service Management”.
• Safety and Regulatory Compliance, Scorecards and KPIs. EDUCATION / TRAINING
B.S. Degree in Industrial Engineer (specialty in Quality) Instituto Tecnológico de Tijuana, México
MIT (Manager in Training) Internal Training
Lean Bronze (Internal Training)
Business Unit Manager (Internal Bootcamp Training) TIME OFF (From 08/23 to 08/24)
• Personal time (Road trip to Baja, expend time with family).
• Self Employed (Develop of Small business that offer supply and services to manufacturing industries in Tijuana BC, Mexico)
• Lean Manufacturing Training
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PROFESSIONAL EXPERIENCE:
PROGRAM / PROJECT Manager (From 05/2012 to 08/2023) Jabil Inc. Oversees and manages (product/customer account) operational aspects and ongoing projects (NPD, NPI) through direct reports (Project Charters, MS Project), coordinate multidisciplinary team to provide sustaining and project priorities, including budgetary administration, request of quotes (RFQ), sales projection and product price review. Owner of account operation and accountable on financial activities
(P&L); Manage and drive internal and customer communication meetings, Quarterly Business Reviews
(QBR), TM1 Financial Information Management (Submit and Review data for Planning, Budgeting and Forecast; P&L Analysis, Variation Reports, Improvement plans, explanation on significant variations, Revenue and expenses projections, etc.). Close follow up of production and project commitments, customer demand, planning “Installed Capacity” and material LT, addresses complex projects, develop resolutions to meet KPI’s, customer goals and plant objectives. PROJECT Engineer (From 11/2008 to 05/2012) Nypro
Maintain the State of Control on the Plant related to assigned account / projects, by the planning, performing, follow up and verification of activities related to NPI, Product Transference and Special Customer projects (NPD).
Intensive participation on plant project for “in house molding implementation”; Documentation and procedures development (IQ, OQ, PQ, Maintenance sheet, Safety Verifications, DHR, Metrology data sheets, GR&R, Equipment Calibration, First Shot management, PFMEA, WIs, Plant lay-out, etc.). Equipment requirements (Dryers, Compressed Air, Temperature controls, etc.). Manage of Master Validation Plan, Equipment Capacity Analysis, Molding Tools Transference, New tool purchasing (Work with suppliers on New Tool Quotes, Tool reparations and Management of Spare Parts,). Coordinates and track of activities / commitments with coworkers (Provide Mentoring and coaching to team), managing budgetary quotes, timelines, and close communication with customers. Q.A SYSTEMS & REG. AFFAIRS COORDINATOR (From 09/2006 to 11/2008) NPA de Mexico Plan, Coordinate, Perform, Support and Verify by Auditing:
• The activities to ensure that all Departments and Material Suppliers related to the company adhere to the requirements of laws and regulations enforced by the US Food and Drug Administration and Quality Systems (ISO 13485 and ISO14971),
• Environmental controls, Customer Complaints and CAPA Systems for full compliance.
• Calibration and Quality Systems Management.
SR. QUALITY ENGINEER (From 03/2003 to 09/2006) NPA de Mexico Support Plant activities related to
• Quality and production lines of assigned areas (4 different customers), Supervision of Q.A resources related to customer accounts.
• Quality System sustaining “Customer Complaints, Training, DHRs, CAPA, PFMEA, NCMRs, SCARs, Internal Quality Auditor)
MANUFACTURING / QA ENGINEER (From 05/2000 to 03/2003) NPA de Mexico Support of production lines for the manufacturing of medical devices (4 different customers). Elaborate assembly methods, production capacity and time studies, BOM’s, routings, line balancing and layout in a high and low volume assembly operation. Conduct engineering and production runs; provide tools and poke-yoke, fixture designs.
• Prepare and conduct Validations IQ/OQ/PQ of equipment and processes.
• Quality systems: Customers complaints (Root cause/Failure analysis), Equipment Calibration control, Raw materials, ISO Coordinator (Implementing Quality systems), Responsible for SPC program and development of suppliers (tubing extrusion, blow molding, cardboards, IFUs,)
• Developed more effective ways to utilize equipment (Primary Packaging, PVC tubing cutter machines,)
• Transfer of new models, materials, and equipment.
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