Continuous Improvement Lean Manufacturing

CELSO DE LA ROSA

* ******* *******, ********** ** 29607

Mobile 864-***-****

E-mail: *************@*****.***

PROFESSIONAL PROFILE

** ***** ** ********** *********** experience together with several Lean Manufacturing and TPM Certificates, Work Measurement Systems, Project Management, Equipment and Process Validation, Problem Solving/RCA based on PDCA and DMAIC methodology, Experienced in FDA, TüV and LRQA Audits, Ergonomic and Safety assessment, Continuous Improvement, Lay Out, Workstations and Production Systems design.

Several years working for Medical devices, Pharma industries (Tableting, Encapsulation, liquid fill, Mixing, Compounding, packaging, etc.) and Electronic Manufacturing Corp. Result-oriented team player with integrity, professionalism, practical experiences, excellent communication, interpersonal and decision-making skills together with a positive approach to problem solving.

SKILLS AND KNOWLEDGE ACQUIRED THROUGH EXPERIENCE

Production/Manufacturing planning and management

Change Control implementation program and improvement,

Cost savings program development.

Training Program development

EHS and Ergonomics improvements

PDCA/DMAIC methodology implementation, Kaizen events, VSM

6S, Lay out and Visual AIDS implementation

TPM facilitator, Maintenance program and Autonomous Maintenance implementation

Filler equipment, Packaging line process design, improvement and equipment validation

URS, SAT, FAT and Validation execution

EXPERIENCES

Haemonetics PLASMA/PHARMA DIVISION

POSITION: Project Mgr. / Senior Manufacturing Eng. /Continuous Improvement Leader 2015-Present

Work with senior leadership to align continuous improvement and Lean Six Sigma initiatives, providing leadership for the strategic direction and financial needs of the site.

Building a lean manufacturing system and Culture from scratch, driving multiple improvement programs and initiatives such as: Production Systems design, Process Validation, 6S implementation, RCA based on PDCA/DMAIC methodology, Kaizen events, VSM, Pull System and Material Handling, Production Efficiency, Cost Improvement Projects, EHS.

Implementing Autonomous Maintenance program

Pharmaceutical processes improvement and process validation for Compounding, Mixing, Overwrap, Bag printing, Fillers and Packaging line.

Other responsibilities include:

oURS Overwrap machines completion

oSAT, FAT and Equipment Validation completion

oProcess flow/Design

oChange Control management

oManufacturing, Facility and Maintenance SOP/SW development

COVIDIEN VASCULAR THERAPIES DIVISION

POSITION: OpEx Lean Corporate Ops Mgmt. & Admin 2012-2015

As part of Core member of the Operational Excellence team and QIP member, I work closely with Divisional or Regional leadership to ensure that continuous improvement; Lean and Six Sigma are across the Manufacturing process division.

Achieving OpEx savings targets and developing skills and capabilities to foster a culture of continuous improvement. Refines and enhances products and processes by applying continuous improvement and key lean manufacturing/production principles and techniques to the production areas: Stents, Drug Coated Balloon, Embolic Protection, etc.

Facilitate and lead Kaizen events, working on different projects such as: Implementing Autonomous Maintenance as a TPM Team Facilitator, Lead plant 5S teams, Poka Yoke, Standard Work, Changeover Time Reduction, Cost Savings Performance Tracking System Design and OpEx project hoper management, Develop training program for RCA (PDCA) and DMAIC, Pull System and Material Handling, Raw Material Scrap Reduction, Calibration tooling control, Design production systems converting manufacturing lines into Cells/Modules.

Developing strategic action plans to support sustainable Cost Savings program for Extrusion and Injection Molding process.

Supporting other sites as a member of the Project Management Team and Lean Manufacturing initiatives.

Some Projects Financial Results:

oReduced Labor cost by 31%

oIncreased production output by 25%

oWIP Reduction: 34%

oIncreased Yield from 88% to 97%

oReduced Lead time from 5 days to 1 day

oReduced OT from 16% to 6%

COVIDIEN MKG AND PHARMA DIVISION (SOLID DOSAGE, CAPSULE, LIQUID)

POSITION: Production Lean Manufacturing Superintendent 2007-2012

Manage about 125 employees splitting in different production shifts, position and production processes.

Production activities planning and tasks assigning to shift production supervisors and Leaders.

Manage operations to achieve safety and production goals

Use Lean/Six Sigma tools to drive continuous improvements, demonstrate a clear understanding of regulatory requirements and of GMP standards through compliance of the Divisional Quality policy.

Facilitate and lead Kaizen events, RCA based on DMAIC and PDCA methodology, TPM Team Facilitator, Lead plant 5S teams, quick changeover. Participate and lead manufacturing dept. CAPA team.

Some Projects and Financial Results

oLabor Reduction by 14%

oIncreased Productivity by 11%

oWIP Reduction by 32%.

oDowntime reduced from 8.8 hr. to 2.4 hr.

COVIDIEN SIMA-USSC- MEDICAL DEVICES DIVISION

POSITION: Senior Industrial Eng./ OpEx-Lean Leader 2003-2007

Assists in leading transfer production lines from other facilities, Coordinate new processes and start-ups with all operational departments and Standardize work in order to standardize the best method to produce a quality product in a safe and efficient manner.

Root Cause Analysis and project leader based on DMAIC and PDCA methodology, Design and development of workstations.

Manufacturing areas design, Lay outs, Manufacturing Metrics, Process Kanban implementation.

6S, Visual Aids and Autonomous Maintenance implementation.

Progressed from the position of Senior Industrial Eng. To OpEx Lean Leader with responsibility for over two engineers and the management of several projects simultaneously for the following production devices manufacturing processes: Laparoscopy instruments, Suture.

Some Projects and Financial Results:

oWIP Reduction by 77%

oOutput increased by 50%

oLabor Reduction by 33%

oSpace Reduction by 495 Sq. Ft

oDowntime reduced from 2.3 hr. to 0.8 hr.

oOEE from 28% to 45%

EDWARDS LIFESCIENCES, A.G. MEDICAL DEVICES DIVISION

POSITION: MANUFACTURING SUPERINTENDENT 2000-2003

Ensure effective preventative maintenance planning and execution, Lead production department in achieving the highest quality product at the lowest possible cost, Manages direct labor costs for assigned lines, Tracks operational results, Facilitate and lead Kaizen events and Lead plant 5S, TPM, SMED teams.

Provide monthly lean manufacturing updates including key metrics.

Coordinate quarterly development Production scheduling, attainment to plan and budget preparations.

Supervision of 5-7 production supervisors (a group of 8 Group Leaders and 210-215 direct labor employees) Review and submit production performance, monthly labor and material variance report.

ABBOTT HOSPITALS, LTD MEDICAL DEVICES DIVISION

POSITION: SENIOR MANUFACTURING SUP. /SENIOR INDUSTRIAL ENG. 1995-2000

Responsible for the strategy and execution of Industrial Engineering and Continuous Improvement across the site.

Develop standard work instructions, Root cause analysis, Design tools and developing manufacturing processes.

Manage cost savings program, Labor standards and material cost.

Carries out supervisory responsibilities in accordance with the organization’s policies including hiring interviews and training.

Promote safety, quality and Good Manufacturing Practices to meet production requirements.

Set operational targets for manufacturing and operations, Supervise a group of 100-128 employees for two production shifts, Provide training and orientation related to job functions.

NAPCO SECURITY SYSTEMS, S.A. ELECTRONIC MANUFACTURING CORP.

POSITION: PRINCIPAL INDUSTRIAL ENG & PROJECT MANAGER. 1990-1995

Coordinate construction activities, equipment installation, and Process design with project engineers and consultants, represent the company in meetings involving negotiations Project Schedule and monitoring of project progress.

Led and supervised a cross-functional team of 3 Industrial Engineers and 2 Project Engineers, Department budget and financial reporting, Develop, implement Cost Savings Project Program, minimize costs and optimize manufacturing processes and Continuous Improvement projects such as:

oNew lay out and Product transfer for manufacturing building (approx. 160,000 sq. ft.)

oManage a budget of US$50MM for the new building and entire site operation transfer

oCoordinate all construction activities project

oLines/Process Transfer of all manufacturing areas, Warehouse, Shipping, Metal shop, Print shop, Office area, etc.

oDesign and development of workstations, manufacturing areas

oDesign production systems converting manufacturing lines into Cells/Modules

EDUCATION

UNIVERSITY: O & M UNIVERSITY

MAJOR: INDUSTRIAL ENGINEERING

LANGUAGES: SPANISH & ENGLISH

TECHNICAL COURSES, SEMINARS & CERTIFICATIONS

A.LEAN SIGMA BLACK BELT CERTIFICATION (in-process)- Haemonetics Corporation

B.LEAN SIGMA GREEN BELT CERTIFICATION, Irvine CA, Covidien

C.LEAN MANUFACTURING CERTIFICATION. Covidien. SIMA, DR ; MKG, NY US

D.LEAN CHAMPION CERTIFICATION ….PRIMEX, Puerto Rico, Edwards Lifesciences, A.G

E.TPM/ TPM FACILITATOR CERTIFICATION, IM&C International

F.BASICMOST CERTIFICATION CARD#16805 (Work Measurement Systems) MAYNARD

G.MTM TRAINING (Work Measurement Systems) Puerto Rico, Edwards Lifesciences, A.G

H.TIMERPRO (Work Measurement Systems) Plymouth, Covidien

I.FDA REGULATIONS TRAINING…Abbott Hospitals, Edwards Lifesciences, A.G, Covidien.

J.BUSINESS FINANCE & STRATEGY…ZODIAK, INC. Plymouth MN, Covidien

K.PROBLEM SOLVING, RCA & DECISION MAKING PDCA, DMAIC, KEPNER-TREGOE’S. New York, USA

L.PROCESS AND SOFTWARE VALIDATION AND PART 11 TRAINING. Covidien. Puerto Rico, US

M.PROJECT MANAGEMENT ….CAPITAL HUMANO. Dom. Rep.

N.ISO 13485:2003 QUALITY MANAGEMENT SYSTEMS…. Covidien.

O.JIT TECNICHS & QUALITY ASSURANCE…INTEC UNIVERSITY

P.2nd.SYMPOSIUM OF INDUSTRIAL ENGINEERING INTEC UNIVERSITY

Q.INVENTORY CONTROL AND MRP SYSTEM... Dominico-American University

KNOWLEDGE AND SKILLS

- SAP, J.D. Edwards, Kronos, BPCS, QAD, Oracle, AutoCAD, Agile

ACTIVITIES AND SOCIETIES

-Former Vice-President of Society of Hispanic Professional Engineers-TC chapter

-Former President of Industrial Engineers of Professional Engineers -DR chapter

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