Engineer Project Manager

Cesar A. Guerra

*** **** ******, ********, ** *7029

pH: 973-***-****

Cell: 347-***-****

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

***************@*****.***

RECRUITER SUMMARY

Has over 5 years of experience as a Project Manager which includes his expertise in Budget, Negotiations, Documentation, Scoping, and Microsoft Visio.

He has extensive experience in Medical Devices and Biotech Industries

SKILLS

ISO 1485, CMM Zeiss Machine, Geometric Dimensioning and Tolerancing (GD&T), PRO-E, CAD/CAM, Microsoft Outlook Project, Microsoft Visio, and Microsoft Office, Six Sigma certification – Black Belt (DMAIC, FMEA, DOE, Gage RER, SPC), SOP (standard operating procedure), MIL-STD-2001, MIL-STD-I-454, MIL-STD-45208, x-ray certification, Teach Pendant Robot certification, OGP system, IPC documentation, GMPS, FDA, QS 9000 system, ASQ certification (e.g. CQE, CMQ/DE, CSSGB, CSSBB), Statistical software certification, IPC-A-610, J-STD-001E-2010, ISO 900, Knowledge of quality control instrumentation testing procedures and inspection control

EXPERIENCE

Zimmer Biomet – Regulatory Affairs Surgery, Est Ohio Avenue, Dover, OH

January 2016 – July 2016

Senior Quality Supplier Engineer Level II

Responsibilities

The scope of this project was quality assurance/regulatory affairs (QA/RA) Remediation and integration plan for a small company acquired by Zimmer Biomet. The general work stream included

Reinforce FDA 483 observation responses (complaint investigations, inspection process, CAPA, Change control)

Remediate/integrate CAPA processes

Remediate/integrate Design History files (DHF)

Remediate/integrate complaint handling process

Remediate/integrate purchasing controls and supplier quality and acceptance activities

Remediate/integrate repair process.

Stryker Orthopedics – Reconstructive, Joint Preservation, and Ortho biologics Dept. Mahwah, NJ

February 2010 - Present

Project Engineer – Advanced Operations

Participate in multifunctional teams, led by a project manager and responsible for defined projects deliverables

Manage engineering change notice for new products from creating to final approval

Negotiations for purchasing machines for new product development of medical Devices macro facial reconstruction

Worked on the projects based on the Allocation of Budget.

Operate within Stryker quality system to produce documentation such as process validations, equipment qualifications, dynamic control plan, inspection plans, and standard operating procedures

Operate within Stryker’s New Product Development Process to build robust processes through involvement in design for manufacturability and lean manufacturing initiations

Utilize Six Sigma process tools such as “Define, Measure, Analyze, Improve control”; “failure modes and effects analysis”; “design of experiments”

Gauge repeatability and reproducibility, and statistical process control as required

Provide input to capital equipment request

Demonstrated understanding or aptitude to understand Medical Device QMS requirements including but not limited to FDA CFR 21 820 and ISO 13485

Understanding of product development lifecycles, design change and document change control methodologies, manufacturing / production process control methodologies and servicing in medical device environment

Quality Engineer responsibilities very important to develops process improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DEO, Gauge R&R,ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validations plans, including Master Validation Plans( Product of Process specific plans) supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliance solutions for product or process corrections, retrospective and remediation action plans, and corrective and preventive actions (CPA Program)

Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklist, worksheets, and other product and process related documentation.

New Jersey Institute of Technology, Research Dept. Newark, NJ

June 2009 – January 2010

Research Assistant

Worked on project entitled “Theoretical Framework for predicting joint reaction and ground reaction forces in a dynamic pendulum tree model of human motion”

Worked on Hedgkin and Huxley’s experiments, ionic currents

Worked on porous Chitosan scaffold and Connexin 43

PPI TIME ZERO – Defense and Aerospace Dept., Fairfield, NJ

March 2006 – April 2009

Process Engineer

Reimburse engineering for aerospace products and quality control documentation

Apply technical understanding for improving manufacturing process, bringing the company into the aerospace industry

Working knowledge of FDA/ QSR, ISO 13485, 2003, quality engineering principles, and quality tools and methods, AS 9100

Applied technical understanding of manufacturing equipment and process for aerospace manufacturing

Non-destructive testing experience such as x-ray, FPI, ultrasonic inspection

Knowledge of Six Sigma/ 80/ Root Cause Analysis

Ability to read blueprints and full understanding of GD&T

Detail knowledge of inspection techniques, tools and methodology

Proven ability to provide consistent quality-driven leadership in validation activities

CMM and CNC programming experience

Statistical software, product engineer

Boeing Corporation – Brazil – Commercial Airplanes Dept. – Boeing 747 and 777

Sao Paolo, Brazil

JUL 2004 – JAN 2006

Production Engineer - Quality and Process Control

Control the assembly process of commercial airplanes

Participate and create documentation for quality control process based on ISO 9001 and applications of MIL-STD-2001, MIL-STD-I-454, MIL-STD-45208, x-ray certification

Create programming for Teach Pendant Robot

Use quality instrumentations for first and final product using OGP system, and Zeiss machine CMM

Collaborated in creation of IPC documentation, GMPS, FDA, QS 9000 system

Developed strong technical writing and interpersonal skills

ASQ Certification (e.g., CQE, CMQ/DE, CSSGB, CSSBB)

Participated in Black Box modification with participation of the following companies: GEC Marconi, BAE systems, Breeze Eastern, U.S. Technologies

Kawasaki Heavy Industries Ltd – Kawasaki Rail Car Dept. Kobe, Japan

November 2002 – December 2003

Technician Engineer

Worked with body assembly and frame welding of rapid transit, commuter, and high speed trains

Application of welding robot

Creation of blueprints for trains using CAD/CAM program

Suzuki Company – Passenger Car Assembly Dept. – Kosai Plant Shizuoka, Japan

January 2001 – October 2002

Manufacturing Technician

Assembly of cars using Teach Pendant Robots

Worked on wiring systems for interior panels for cars

Worked in body shop using welding machines

Inventory process control for automobile parts

EDUCATION

M.S. in Biomedical Engineering April 1995 – December 1999

University Of Sao Paolo – Lorena – Centro De Bioteciologia

B.S. in Mechanical Engineering April 1990 – December 1994

University Of Catolica

High School Diploma April 1985 – December 1989

SAINT THOMAS HIGH SCHOOL

LANGUAGES

English, Spanish, Portuguese, and Japanese

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