Manufacturing Engineer

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ARNOLD J. RODRIGUEZ IRIZARRY

(*********.*******@*****.***)

P.O. Box 341 Home 787-***-****

Coamo, PR, 00769 Mobile 939-***-****

EDUCATION

2012

Universidad del Este,

Santa Isabel, PR

M.S. Sociology

2008

University of Puerto Rico,

Mayagüez, PR

B.Sc. Industrial Engineering

*ABET Accredited

EXPERIENCE

Sept. 2015 to Present Baxter Healthcare Corportation

(Pharmaceutical Industry), Jayuya, Puerto Rico

Process & Product Engineer Consultant

Served as an independent Contractor supporting Validation activities.

Designed, Generated and Executed Process Validations for continuous improvement in the Manufacturing Department.

Used Statistical Techniques to support improvements.

Coordinated Protocol Executions across all departments.

Identified areas of improvements and supported FDA commitments.

Jun. 2014 to Jun. 2015 Zimmer Manufacturing B.V.

(Medical Devices), Ponce, Puerto Rico

Manufacturing Engineer Consultant

Served as an independent resource making recommendations on Manufacturing Engineering process of inspection methods per Drawing Specifications for manufacturing tools and/or fixtures, used to manufacture finished goods (hip implants).

Designed Test Method Validations in order to have solid evidence that the equipment is suitable for its intended purpose.

Evaluated manufacturing processes applying knowledge of statistical techniques in order to provide recommendations for improvements.

Determined the correct approved supplier for an off-site testing of tools/fixtures, based on feedback of testing methods, company needs and costs.

Assured product and process quality by validating testing procedures to confirm compliance with FDA Regulations.

Designed, executed, analyzed, and implemented procedures for inspection methods.

Oct. 2012 to Jan. 2014 St. Jude Medical Inc, (Medical Devices)

Caguas, Puerto Rico

Associate Quality Engineer

Provided guidance and support, to Quality/Facility/Manufacturing, to ensure design control compliance.

Lead support to ensure applicable industry standards, regulatory requirements and customer requirements, monitoring clean room conditions, inspection data behavior through SPC and generated/implemented corrective/preventive actions as needed.

Investigated Non-Conforming materials to find the root-cause and generate corrective and preventive actions, applying Lean Manufacturing/DMAIC techniques.

Performed test method validations using Gauge R&R (from generation of the protocol, execution, analysis report, training, implementation, SOP updates and continuous improvement).

Ensured compliance to ISO 13485 & 21CFR 820 Quality System Regulations through internal audits.

Oct. 2011 to Jun. 2012 Kelly Services (Hamilton Sundstrand),

Santa Isabel, Puerto Rico

Manufacturing Engineer for the Manufacturing/Engineering/Quality Assurance department

Part of a multidisciplinary team hired for product transition to local manufacturing site.

Generated new assembly procedures (Job Instruction Sheets), for New Product Introductions, including defining product routing which derived from Product Drawings, and from Process Engineers input.

Reviewed documentation and implement Engineering Changes and Process Revisions to new and current assembly procedures.

Coordinated the work input of the cell in order to maximize output and comply with project deadlines along with daily demand.

Lead of manufacturing - quality cell for workflow optimization, applying one piece flow and designing discrete event simulation.

FAA regulated manufacturing company.

Support shop floor personnel to ensure quality and availability of assembly procedures.

Applied Lean Manufacturing / Six Sigma reducing waste (rework).

Aug. 2007 to Dec. 2007 CCTV at RUM,

Mayagüez, Puerto Rico

Layout Project

Maximized space usage using 5S and AutoCAD.

Impemented a one-piece-flow process.

Implemented two of the three steps of the proposed model, that minimized waiting times, maximized process flow, and optimized the system.

Jan. 2006 to May 2006 Banco Popular de Puerto Rico,

Mayagüez, Puerto Rico

Time Study Project

Optimized service times using queuing theory.

Developed an Optimization Model with ARENA

simulation software in order to determine areas of

opportunity in the system.

Implemented the proposed dedicated human server for the auto bank service.

CAPABILITIES

Quality / Results oriented with a combination of Six Sigma and Lean Manufacturing techniques.

Excellent leadership skills; willing to assist/lead others in a teamwork environment.

Simulation Modeling Optimization.

Lean Manufacturing mind-set, waste reduction.

Works excellent under pressure, and adapts easy to difficult situations.

Strong analytical and SPC skills.

Outstanding problem solver.

Fully bilingual: English and Spanish. Excellent oral and written skills.

COMPUTER HARDWARE: IBM PC and compatibles.

SOFTWARE: Word and Excel for Windows, Microsoft Power Point, Microsoft Access, C-Language, and Arena 8.0 (SIMAN), JDE, WindChill, Internet Research, SAP.

STATISTICAL SOFTWARE: Minitab, MathCAD, Stat Fit, and S-Plus.

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