Principal Engineer

Engineering Experience in Manufacturing/Process Operations; class III

Medical Devices manufacturing Environment and Petrochemical/Refinery

Processes ( Managed High Profile Projects to Successful Results (Two

facility start-up contributor ( Earned World Class Awards for Exemplary

Performance ( Earned BSCHEE/CHE Degrees

Result oriented engineer focused in problem solving, process optimization

and new technology/product transfer.

Core Skill Areas

Production Solutions Analysis & Implementation; Six Sigma & Lean Manufacturing

Methodologies; Green Belt Certification; High Tech Production and Maintenance

Operations; Process Analysis, Evaluation & Troubleshooting; Regulatory Affairs

& Compliance; Ethylene Oxide Sterilization, Sterile/Final Packaging, Controlled

Environment and Sterility Assurance, Thin Films Coating (gold, parylene)

Deposition Processes; Medical Adhesive and Epoxy Applications;

Infrared/Convection Heat Curing; Aqueous and Organic Solvents, Atmospheric and

Vacuum Plasma Cleaning processes; Resistance Spot, Parallel Gap and Ultrasonic

welding; Surface Finishing using ((Soda, Grit, Bead) Blasting, Buffing,

Straight Line); Custom Design Builds; Sanitation Procedures; Fluorocarbon

Solvent Recovery; USP Water Systems; Chemical/Metallurgical/Microbiology

Laboratory Analyses.

Professional Experience

Medtronic CRDM, Juncos PR 1978 to 2012

Principal Mfg. Engineer, 12/2004 to 3/2012

Sr. Mfg. Engineer, 4/1984 to 11/ 2004

Q.A Engineer, 1/1980 to 3/1984

Chemical Engineer, 6/1978 to 12/1979

. As a Principal Mfg. Engineer: Lead new product/technology transfers,

Process development and improvement using Lean and Six Sigma

methodology. Interact with global team members to define and implement

innovation strategies. Support manufacturing process for IQ-OQ-PQ

activities, equipment troubleshooting, Preventive Maintenance and

Calibration procedures implementation. Disposition of non-conforming

products/material from mechanical, chemical and sterilization process.

. As a Sr. Mfg. Engineer: Provide Manufacturing Engineering support in

all areas of process and product technology transfer and development

as related to the manufacture of implantable pulse generators. Analyze

performance versus product quality to implement or develop process

changes to optimize yields and reduce production cost using Just-In-

Time and Quality Improvements Process Techniques. Generate and execute

equipment and process validation protocols (IQ, OQ & PQ) to ensure the

highest quality level. Analyze and dispose discrepant product

providing action to prevent reoccurrence. Provide guidance to less

experience engineers and prepare all required training courses to

improve production worker knowledge on product manufactured.

. As a Q.A. Engineer: Prepare or modify procedures to assure systems

efficiency and product quality. Coordinate and work on new products

and/or technology transfer teams to make them successful. Design,

prepare and review IQ, OQ and PQ plans and reports to insure they meet

company and FDA guidelines. Participate on FDA, TUV and corporate

audits and ensure compliance with internal and external audit

findings. Identify critical process variables for manufacturing

equipment to develop projects to improve quality, safety, cost

efficiency and reduce production cycle times. Work with the

implementation of corrective/preventive actions to reduce or eliminate

defects. Provide analysis and evaluation to non-conforming

product/material and implement pertinent corrective actions.

. As a Chemical Engineer: Implement and perform

metallurgical/chemical/microbiological laboratory analyzes for

supporting manufacturing operations. Implement and operate solvent

Freon TF recovery system. Support Parts cleaning manufacturing area,

12/88 % ETO Sterilization Process and USP Deionized Water System.

Achievements

. Facility Start-up of Microbiology, Metallurgical and Chemical

Laboratories to support manufacturing operations.

. Lead Implementation of key projects such as; 12/88 % ETO Sterilization

Process, 100 % ETO Sterilization Process with Parametric Release,

Automated System for Continuous Monitoring of Sterilization

Parameters, Freon TF Solvent Recovery Process, Ultrapure Deionized

Water System, Non CFC Chemicals cleaning processes, Plasma Cleaning

Process, Gold Coating Process and Parylene Coat Process.

. Key Contributor to the Zero Observation Result of First FDA Audit

Activity at Medtronic facility.

. Yield improvement Project for Parylene Coat Process. Implementation of

Parylene Coating process quality and productivity improvement

initiatives to significantly reduce parylene DPMs, TPCT, Rework, PRB

and Scrap.

Education & Activities

Bachelor of Science, Chemical Engineering, University of Puerto Rico

Bachelor of Science, Chemistry, University of Puerto Rico

Chemist License #2535

Green Belt Certification

Honors & Awards

Two (2) Medtronic Star of Excellence World Class Awards;

. Customer Focus Quality Star of Excellence World Class Award

. Six Sigma Integration Star of Excellence World Class Award

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