ERWIN VILLANUEVA, PMP, CQE
** ********** ********* *****, **********, NJ 08872
Phone: 908-***-****; Email: ****************@*****.***
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