Six Sigma Engineer

****N BAYSHORE Mobile: 787-***-****, Other: (***)

DR. 258-2064

MIAMI FL 33132 *****.**********@*******.***

Sacha G. Valenzuela Quir s

Objective An opportunity with a well established company offering

excellent opportunities to contribute to achieve and exceed

Skills Profile business goals based on demonstrated performance in the

production and process control field.

Excellent communication skills (oral and written) / English

and Spanish.

Able to work under pressure and minimum of supervision.

Good interpersonal skills. Motivated with can-do attitude.

Teamwork oriented and refined leadership skills.

Good industrial engineering background, tools and techniques.

Problem-solving skills using and extended mathematical and

engineering background.

Experience Aug 2006-Oct 2009 Medtronic PR Operations

Juncos, PR

Manufacturing Engineer

Plan and design device manufacturing processes.

Maximize efficiency by performing capacity analysis by

analyzing layout of equipment, workflow, assembly methods, and

work force utilization.

Perform ergonomic assessments and improvements implementation

(i.e. human factor and work station re-design).

Determine parts and tools needed in order to achieve

manufacturing goals according to product specification.

Perform a variety of task, under general supervision reporting

to area manager.

KPI - Key Performance Indicators monitoring (operations and

process Yield %, DPMO, Failure Rate, Scrap)

Work directly with process technicians and manufacturing team

members in order to find out areas of opportunity and

improvements.

Inventory control and planning based on demand (MRP).

Conduct weekly meetings to employees for KPI deployment, not

limited to trainings and employee awareness for compliance

issues.

Initiate and promote investigations for non-conformance

product, process or material following NCR, MRB, PRB, FA, RCA

or CAPA procedure based on the nature of the event.

Initiate and promote Continuous Improvement (CI) and Process

Excellence initiatives in conjunction with business partners

at Medtronic Minimed in Northridge, CA.

Request and Implement engineering change orders (ECR/ECO).

Modify products build profile, process plans, BOM in FW, JDE

and SAP.

Process, Software and Equipment qualification/validation (IQ,

OQ, PQ, & PPQ), not limited to product transfers.

Production work emphasizing Lean Mfg practices: Kanban, 5S,

Kaizen, One-Piece-Flow, Poka-Yoke

Perform manufacturing assessments to identify process

improvement initiatives.

Perform continuous improvement initiatives as project leader

or team member by executing Lean Six Sigma Projects or Kaizen

events.

As trainer, encourage the manufacturing operators to use

continuous improvement techniques by developing their

capabilities as Yellow Belts.

Process Excellence documentation following Lean Six Sigma

(DMAIC) methodologies.

Problem solving tools: DMAIC, Kepner Tregoe

Certified Lean Six Sigma Green Belt.

May 2005- Aug 2006 C.R. BARD

Humacao, PR

Validation Engineer

Main Core: Facility Transfer Activities

Develop and Execute validation protocols, reports and

trainings for IQ, OQ, PQ & PPQ, and Master Validation Plans

for cardiovascular, urology, suture fabrics, meshes, hernia

patches and biopsy product lines, not limited to cleaning

validation.

Develop Process Capability analysis (confirmation runs,

process/equipments characterization, etc.) to determine the

process variability for pre and post transfer activities (e.g.

pre/post sterilization, packaging, cleaning processes)

Strong experience in packaging equipment such as blister and

pouch sealers. Not limited to testing, perform capability

analysis, create or modify PM and calibration procedures,

generate and execute qualification/validation,

characterization studies.

Develop Root Cause Analysis using DMAIC methodology, Failure

Investigations and Monitoring Control Plans to assure the

confirmation of process parameters and the integrity of the

finished goods.

CAD Drawing.

Documentation following cGMP, FDA, QSR and ISO best practices.

Other Areas:

Mfg Lines support (Procedures, BOM, Documentation, Drawings,

etc.)

Plug Former Particle Matters cost saving project; over $200K

on registered savings.

June thru Dec.-2004 HANES Brand Humacao,

PR

Division of Saralee Intimate Apparel & Hosiery

Process/Quality Engineering Technician (Co-oP)

Intimate, hosiery and sport apparel manufactured in Santoni

automated machines and chemically dyed.

Process support focusing on product quality assurance and

process control.

Manufacturing line optimization and monitoring based on

process metrics such as Yield%, Scrap, and Failure Rate.

Non-conformance, complaints and supplier events evaluation

(including reports generation), and corrective/preventive

actions implementation.

Continuous improvement implementation based on Lean

Manufacturing practices (5S, Visual Factory, Kaizen).

Packaging optimization and Layout re-design.

Documentation and work oriented in Lean manufacturing

practice, QSR and ISO 9000.

Technical supervisor and Employee trainer.

June thru Aug.-2003 Verizon\PR Telephone Co. San

Juan, PR

Engineering Intern

Implement CRM technology (Siebel Platform).

Work with the Engineering Planning team developing the

division forecast for the CaPEX 2004.

Education Present Polytechnic University of

Puerto Rico

San Juan, PR

M.S.E., Manufacturing Engineering, majoring in Quality

Management (50% complete)

Master Courses: Lean Manufacturing, Foundation in Quality

Learning & Assurance, Engineering Packaging Technology, Design

& Implementation of Statistical Sampling Plan, Assessment

Tools for Business Improvement, Pharmaceutical Technology I &

II: Solid & Semisolid Dosage.

May 2005 Polytechnic University of

Puerto Rico San Juan, PR

B.S.E., Industrial Engineering

Professional Certified Green Belt Lean Six Sigma from Medtronic Process

Certifications Excellence Academy

Lean Six Sigma Yellow Belt's Trainer

EIT examination approved (April 2005)

Training/

Seminars cGMP

QSR, FDA Regulations for the medical device industry

(21CFR820.)

ISO 13485

Lean Six Sigma Green Belt

Understanding Plasctics and Basic Principals, by PhD. Ivan

Baiges

Documentation & Writing skills, by. PhD. Pepe Rodriguez

Ultrasonic Welding, by. Plastex

Automated Adhesive Dispensed, by. Creative Automation

Software MS Office suites, MS Project, MES, Trackwise, QUMAS, AutoCAD,

Solidworks, Cristal Reports, Minitab, Statgraphics, SPICE

Reference (SPC), JDE, SAP, PLC

I will be glad to submit any other information upon request.

Contact this candidate