Process Improvement & Engineering Project Manager

PAVEL PAUL ZAGULA

**** ***** *** *****, ****, North Carolina 27539 (C) 919-***-**** *******@****.***

Professional Summary

Highly skilled and talented Engineer and Project Manager with a broad range of expertise in Designing, Manufacturing and

Production Processing for Pharmaceutical and Medical Devices field. Possess a hands-on experience with variety of designing

software like Solid Works, AutoCAD and Master Cam. Demonstrates a solid knowledge of Project Management, Validation and

Quality Assurance Principles, and has a proven track record of Continuous Process Improvement with use of Lean Six Sigma

Methodology in accordance with cGMP Standards. As a Project Manager successfully delivered several projects with over $10

million budget combined. Experienced, charismatic and valued Manager and Team Leader.

Skills

• Project Manager Certification from Villanova

University

• Six Sigma Green Belt Certification by Aveta Institute

(Black Belt in progress).

• Cognex Vision System Advanced Certification.

• Product design and review with Solid Works and Auto

CAD.

• Lean Manufacturing, DFM and DFA and GMP

Standards and Principles.

• Performance optimization, and Failure Analyses and

FMEA.

• Expertise in troubleshooting and creative problem

solving-CAPA and RCA.

• Broad knowledge of QA, Validation and Medical

Regulatory, HVAC/cGMP, FDA 510(k) and ISO

13485.

• Proficient in four Foreign Languages.

• Proficient in MS Project Manager, Excel, MS Office.

Work history

SENIOR ENGINEERING PROJECT MANAGER 09/2012-present

Biomerieux, 100 Rodolphe St. Durham, NC 27712, USA

• Plan, develop, manage and implement project plan to meet business needs and make decisions to carry out the plan.

• Provides technical expertise and support to Manufacturing and Quality Control processes in manufacturing of In Vitro

diagnostics.

• Initiates and completes Process and Document Change Controls

• Leads manufacturing projects within current QSR & ISO guidelines while maintaining compliance to Safety and

Regulatory requirements for pharmaceutical industry.

• A member of Lean Six Sigma Board, which contributed to multi million dollars “scarp” savings over years.

• .Successfully initiated, integrated and delivered several of Continuous Improvement Projects.

• Lead and participate in Lean Six Sigma “cross functional” teams.

SENIOR ENGINEER / PROTOTYPING DEPARTMENT MANAGER 03/2009 to

09/2012

Transenterix – 635 Davis Drive, Suite 300, Durham, NC 27713, USA

• Played a key role in designing and prototyping medical devices that help reduce the invasiveness of surgery for

patients while enhancing the capabilities of surgeons that resulted in launching a break through surgical SPIDER SYSTEM.

• Assisted in Clinical Research, including Porcine, Poultry and Human Cadaver.

• Involved in designing, prototyping, launching and transferring products to Manufacturing.

• Promoted to Engineering Prototyping Department Manager contained of 12 Engineers.

MECHANICAL PROCESS ENGINEER 07/2004 to

02/2009

Madern USA – 1010 Burma Street, Apex, NC 27526, USA

• Managing the manufacturing process flow in accordance of cGMP Standards.

• Developed and implemented Manufacturing Directions and Standard Operating Procedures.

• Participated in designing of new products with accordance of DFM/DMA principles.

• Created blueprints, work instruction, sketches, drawings and manuals to determine dimensions and tolerances.

• Leading Failure Analyses and Continues Process Improvement Teams.

MECHANICAL ENGINEER 03/2002 to

06/2004

Tomsed Corporation – 420 McKinney Parkway, Lillington, NC 27546, USA

• Played key role in designing and manufacturing of turnstiles, security gates and barriers with use of Auto CAD.

• Administrated projects into production within cGMP Standards.

• Supervised daily production department of 30 employees during in the absence of the department manager.

• Reduced amount of “waste” by implementing Six Sigma Methodology.

R&D PROJECT ENGINEER 01/2001 to

02/2002

Knoll Pharmaceuticals – 3000 Continental Dr. North, Mt. Olive, NJ 07828, USA

● Participated in the development of the incubator for a new molecular test to monitor for recurrent bladder cancer.

The technology patent was acquired by Abbott Technologies and released under the Vysis UroVysion trademark.

PROJECT ENGINEER 08/1998 to

12/2000

Pegaspol – ul. Srebrna 160, Katowice, POLAND

• Researched product brief to develop market fundamental understanding of customer applications for variety of medical

wheelchairs. Deeply involved in developing manufacturing and assembling process risk analysis in accordance to medical

Regulatory, including ISO 9001, etc.

• Member of the design team who pioneered the concept of 3 wheels wheelchair, to increase mobility, and accessibility.

• Talent of The Year Employee Award in 2000

R&D ENGINEER 04/1996 to 08/1998

Hellma Italia S.p.A – Via Gioaccino Murat 84, Milano, ITALY

• Participated in research of optical components for broad range of Spectroscopy instruments (scanning devices, optical

sensors, etc.)

• Designed 3D models of complex optical assemble housing, like Linear Opthomalic Spectroscope

• Generated ideas and solutions for use of fibber optics diode array system for breast cancer detection.

PROCESS ENGINEER 01/1995 to 03/1996

Moto Guzzi S.p.A ( formerly G.B.M. S.p.A) – Via E.V. Parodi 57, Mondello del Lario, ITALY

• Developed manufacturing process for production of high tolerance parts, like pistons (within 0.01 mm).

• Oversaw the transfer of projects from R&D to the production process.

• Interpreted drawing mark ups and implemented drawing revisions provided by engineers on the shop floor.

• Assisted technical support department and QA in troubleshooting product returns and after-sales support.

Education

Masters of Science (MSME) BIO MECHANICAL ENGINEERING University of Science and Technology

(Akademia Gorniczo Hutnicza) - Krakow, POLAND (accredited University) 2000

Bachelor of Science (BSME): MECHANICAL ENGINEERING University of Applied Science Oslo

and Akershus (Hogskolen I Oslo og Akershus) - Oslo, NORWAY (accredited University) 1994

ADVANCED PROJECT MANAGEMENT Villanova University, USA 2013

LEAN SIX SIGMA GREEN BELT CERITIFICATION Aveta Business Management Institute 2013

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