ERWIN VILLANUEVA, PMP, CQE

** ********** ********* *****, **********, NJ 08872

Phone: 908-***-****; Email: abhpbf@r.postjobfree.com

EDUCATION

BS- Mechanical Engineer, New Jersey Institute of Technology (NJIT)

CQE Certified, American Society for Quality (ASQ)

PMP Certified, Project Management Institute (PMI)

Quality Engineer Certificate, ASQ

Project Management Certificate, Rutgers University

ISO 9001/13485/ 14969 Training, ASQ

PROFESSIONAL EXPERIENCE

Engineering Manager, LaJobi, Ind. - Cranbury, NJ (11/2008-Present)

Developed project plans, schedules, WBS, and identified deliverables;

95% on time delivery.

Managed the organization's engineering and product design; revenue

increase $10M.

Authored and championed the implementation of the organization's

quality manual, and Quality Management System; product development

time reduction 20%

Developed product design guidelines, managed the organization's

ECR/ECN system, and implemented Product Risk Assessment programs

(FMEA); defect reduction 10%.

Efficiently managed and mentored technical staff in Vietnam, Thailand,

and China.

Actively involved in the development of Juvenile standards with the

CPSC, ASTM and JPMA.

Project Manager, VIRA Manufacturing, Inc. - Perth Amboy, NJ, (11/2007-

11/2008)

Successfully managed the design, and installation of millwork for new

construction banks within 5% budget, and 100% on time delivery. Total

project value $600K.

Effectively coordinated the design, production, and installation of

store fixtures for 7 new stores with a 10% profit increase, and 100%

on time delivery. Total project value $800K.

Managed the design, manufacturing, and installation rollout of store

fixtures for 50 new stores with 90% improved quality. Total project

value $4M.

Qualified and audited vendors, and met cost reduction goals; 7% cost

reduction.

Engineering/ Project Manager, MAJESTIC Industries, Inc - Passaic, NJ

(10/2006-11/2007)

Effectively created and executed project work plans, and managed day-

to-day operations.

Successfully designed and developed ergonomic seating; revenue

increase $2M.

Improved production efficiency by 20%, and decreased manufacturing

errors by developing standard operating procedures (SOP), in-line

inspection, and work order documentation.

Effectively supervised 40 employees, and mentored the manufacturing

department to implement LEAN manufacturing principles, product

verification, qualification, and inspection plans.

Qualified new vendors and implemented cost reduction programs; 10%

cost reduction.

ERWIN VILLANUEVA, PMP, CQE - Page 2

Sales/Project Manager- Consultant, RIA CONNECT, Inc. - Tinton Falls,

NJ (9/2005-9/2006)

Successfully managed the development of European style terminal block,

and modular jack product lines in the US North and South East, and

Eastern Canada regions; total value $4M.

Successfully obtained interconnect design-wins with Motorola,

Honeywell, and Tyco Electronics. 10% territory growth.

Efficiently managed the organization's sales forecasting system and

trained distributors.

Quality Engineer-Consultant, CONVATEC - Skillman, NJ (7/2004-7/2005)

Supported new product development, and existing product maintenance by

providing design control guidance to ensure FDA compliance of medical-

devices.

Worked with the Chronic-Care group in execution of change evaluation

plans and specification.

Coordinated Risk Management evaluations (FMEA/FTA) on new and existing

products, ongoing risk monitoring, and change control activities.

Efficiently managed the design transfer of over 20 medical devices to

third party manufactures.

CAPA management; reduced failure recurrences by 95%.

Project Manager, WESTINGHOUSE AIRBRAKE TECH - Laurinburg, NC (7/1998

- 5/2004)

Efficiently developed full-scale project plans, defined project tasks

and resource requirements for AMTRAK, New Jersey Transit, NY City

Transit projects; Value $6M.

Reduced projects' risk by developing contingency plans, and

implementing active threat and opportunity management methodology;

project completion rate improvement 70%

Successfully developed new product field-tests protocols and performed

product verification, validation, and qualification in South America,

Canada, and Mexico.

Introduced and qualified new railroad friction products in South

America, North America, and Mexico; revenue increase $1.5M.

Facilitated international technical team and client meetings.

Trained and mentored technical staff in product qualification

procedures; approval rate 90%.

Participated in KAIZEN projects to improve manufacturing process; 90%

cycle time reduction.

Preparation of bids and contract negotiations; $10M executed and

awarded bids.

SKILLS & PROFESSIONAL TRAINING

Pro/ENGINEER, INVENTOR, AutoCAD 2010, Adobe Photoshop

MS Products - Word, Excel, PowerPoint, MS Project, MS Visio

ISO 9001, ISO 13485/14971/14969, Design Control Requirements for

Medical Devices

GMP/FDA Manufacturing, CFR Part 11, 210, 211, 820, Medical Devices

Human Interaction, R&R Studies, and CAPA Implementation, GHTF

Documented Guidance

Training Risk Management, Process Risk Analysis, and Design Control

for Medical Devices

Training in Reliability, failure rates, availability, MTTR, MTTF, and

system reliability

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