Principal H Engineer

DAVID C. WOJEWODA

** ******** *****

Londonderry, NH 03053

Home: 603-***-**** *******@*******.***

SUMMARY

An accomplished senior engineer/manager with a history of proven results leading teams in global markets. A continuous learner,

having a bioengineering/medical education from Tufts University, focusing on medical imaging, design of medical devices and

human physiology. A cross-functional team leader, with direct NPI/PCP and customer service experience. Skilled in quality

management systems, possessing a 2008 six sigma Green Belt Certification. Intimately involved in product development and

sustaining efforts to optimize customer’s satisfaction. A champion of supply chain activities involving custom developments,

manufacturing transfer, cost reductions and EOL sourcing. An expert at using strong oral and written skills to obtain and

document requirements and results. Knowledgeable of regulatory/product compliance guidelines. Experienced in CMMI and

other process and documentation/validation. A personable, conscientious, versatile, and knowledgeable professional with a

history of successes for world-class companies.

AREAS OF EXPERTISE

Sustain Engineering and Product Improvement/Serviceability NPI/PCP

Product and Component Qualifications (DVT, V&V, DOE) Quality Assurance

Building and Managing teams Project Management & Scheduling

Customer, EMS & Vendor Interfacing Engin. Failure Analysis (EFA)

Regulatory & Safety Testing (Telcordia, UL, NEBS, CE, CSA, ETSI, FCC, RoHS) Six Sigma DMAIC Green Belt

PROFESSIONAL EXPERIENCE

MOTOROLA MOBILITY (GOOGLE), Lowell, MA 2006-2012

Principal Staff Engineer/Manager, Electro-Mechanical Hardware Sustain Engineering 2011-

2012

Lead mechanical engineer responsible for multi-site hardware development and sustaining efforts for profitable, high volume,

electro-mechanical devices. Directs cross-functional support for customers, EMS and vendors, focusing on quality related issues

at all product levels. Overall program management of third-party product development engineering teams. Complete product life

cycle accountability. Lead team’s efforts to produce robust, quality products exceeding the customer’s expectations. Interfaces

closely with SW group to provide seamless product enhancements.

• Customer interface for all ECRs (Engineering Change Requests). Liaison to customer to resolve critical product reliability

and serviceability issues. Complete resolution responsibility to address customer’s feedback. Develop specifications, costing

and scheduling for new designs and enhancements. Interface with cross-functional teams to ensure proper implementation.

• Managed and led team’s efforts in EFAs. As a certified Green Belt, used six sigma DMAIC methods to determine and resolve

root causes. Systematically reduced the cost of poor quality (COPQ) across product lines to achieve substantial cost savings.

Chairs weekly meeting discussing and scheduling corrective actions (CAs).

• Part/Component qualification for EOL, replacement, and cost reduction resolutions. Create, perform and formally document

all efforts to allow for internal and external audit traceability. Use six-sigma techniques to hypothesize, and prove alternative

components are acceptable. Utilize statistical data provided by Minitab operations, to support decisions. Data mining using

WDA and OBIEE software to identify defect trends for resolution.

• DVT (Verification and Validation) extensive evaluations of new products and components to ensure performance meet all

requirements. Creation of thorough, detailed and precise technical documents explaining test processes, and results.

• Coordination of team’s efforts to qualify a new manufacturing site, of a large variety of technical products, in China. Lead

engineer performing FAIs, documenting results, and rectifying all process and product issues encountered.

• Manager of all hardware related ECNs. An expert of PDM operations. Intimately involved with product Change Control

Board (CCB) to ensure modifications are properly documented, implemented, and affect to production is minimized.

• New product design and documentation using PRO/E CAD modeling tools, and Windchill product data management.

Involved with high volume injection molded plastics and extruded metals for use in multiple environments.

• Champion of business unit’s “Green” initiative to reduce environmental footprint and overall costs. Introduced packaging

innovations to reduce costs by more than 20%, and completely eliminated the environmentally unfriendly use of foam.

• EMS (Electronic Manufacturing Services) interface. Regularly interface with factory personnel in China to resolve technical

issues related to the product and process. MOL(Maintenance of Line)

Compliance Manager 2010-2011

Directed team’s efforts in delivering qualified products to market. Customer interface developing and coordinating test plans to

meet regulatory requirements. Intimately involved in product compliance and safety.

• Coordinated and performed testing at ITLs. Collected and maintained formal documentation of all testing and approvals.

Extensive testing to meet NEBS, ETSI, Verizon, UL, CSA, CE and FCC specifications. Responsible for expenses exceeding

$500K annually.

DAVID C. WOJEWODA PAGE TWO

Senior Staff Engineer/Manager, Electro-Mechanical Hardware SustainEngineering 2006-2010

• Responsible for establishing high volume manuf. transfer to China. Intimate involvement in supply chain activities including

supplier selection/integration, price negotiating and custom product development.

• Collaborate regularly with engineering teams in Taiwan, China, India and multi US locations to resolve vital engineering

issues. Consistently providing rapid resolution of critical issues allowing for increased customer satisfaction. This includes

new feature and EOL modifications. Fully committed to delivering product improvements as scheduled, and meet cost goals.

• Established and chaired a weekly teleconference involving field service personnel to address all formally recorded customer

issues. This concentrated group dialogue is credited with decreasing open issue time by a minimum of 25%.

• Mechanical engineer responsible for the transition of entire engineering support team from CA to MA. Global interfacing

with team members and partners. Relocation successfully completed as scheduled, without loss of production and revenue.

RAYTHEON, Tewksbury, MA 2004-2006

Senior Systems Engineer, Mission Effectiveness (Integrated Defense Systems) 2004-2006

Responsible for determining, analyzing and specifying system requirements. Coordinated the development of department

standards and procedures to yield more efficient time utilization.

• Developed concepts of operations (CONOPS) for various war fighting systems. Performed threat analyses and notional lay

downs to aid in end item assessment and determinations. Initiated trade studies and risk assessments for various scenarios.

Utilized Matlab software to perform and determine threat situations.

• Collaborated with cross-functional teams to develop proposals and marketing presentations for government officials. Created

technical documentations, including system functional descriptions and other technical manuals.

• Championed departmental introduction and implementation efforts of various programs including; Capability Maturity Model

Integration (CMMI) and a technical skills inventory and competency model, utilizing SAP database.

LUCENT TECHNOLOGIES / BELL LABORATORIES, North Andover, MA 1983 – 2003

An accomplished history of design, process and product engineering, encompassing component to complete system-level

integration. An expert at managing teams to produce highly technical products. Innovative techniques earning recognitions and

continuous top rankings. A dependable team player eagerly accepting new challenges with minimal guidance. Product-line

responsibility interfacing to both design and manufacturing groups. Advocated DFM and lean practices enabling schedules and

costs to be maintained. Direct customer and vendor interface, accountable to the quality management system (QMS).

Physical Design Engineer (Senior/Lead) Hardware Development of Telecom Equip’t Bell Laboratories 1995-98, 2000-03

• Lead mechanical engineer responsible for researching, designing, scheduling, fabricating, and delivering high quality

communication equipment. Acted as liaison to customers and suppliers for problem resolutions. Determined/collected

requirements, assessed risks, developed scheduling and staffing requirements, delegated responsibilities and collaborated with

CFTs to ensure seamless transition to manufacturing. Provided technical information utilized for the creation of marketing.

Negotiated with potential vendors to develop and price materials and products.

• Appointed to special project team charged with the creation of a new product introduction (NPI) process area, later used as a

model for future manufacturing lines within the facility. Awarded Lucent President’s Award for outstanding engineering

achievement. Involvement in product from conceptualization to installation. Performed all compliance/validation testing.

Field Engineering Manager 1998 – 2000

• Accountable for coordination, transportation and installation of large telecom equipment for a variety of customers. Directed

a group of installation engineers and technicians in the start-up of telecommunication equipment in challenging environments.

Manufacturing/Product Engineer (Senior/Lead) 1992–

1995

• Executed the transfer of entire product line from Europe. Coordinated supply chain strategies reducing delivery times,

inventories and costs.

Manufacturing/Process Engineer 1991 –

1992

• Introduced customized handling systems to increase throughput and yields. Performed validation testing. Utilized SPC

techniques to increase and monitor process quality.

Mechanical Machine Design Engineer, OEM Manufacturing Equipment 1983 –

1991

• Successfully demonstrated mech. design responsibility for the fabrication and installation of OEM equipment used in the

manufacturing of high-tech products.

EDUCATION

BS, Mechanical Engineering, University of Massachusetts, Amherst, MA 1983 (GPA 3.3/4.0)

Bioengineering Masters degree Program, Tufts University, Medford, MA 2003/2004 (GPA 3.8/4.0)

AWARDS AND PATENTS

Performance awards and bonuses every year offered Holder of three (3) United States Patents

April 2, 2013

Senior-level, Engineering or Management Position

Re:

My education and industry-provided experience makes me a strong candidate for a Senior-level Engineering or Management

position. The job description lists the functions performed at Motorola as a Principal HW Engineer. Although the product lines are different, the daily

duties are the same. I have successfully managed teams, and know how to create an enthusiastic work environment. My role has been versatile; from NPI to

EOL, I consistently work with CFTs to provide high quality products in a timely manner. I had full maintenance of line (MOL) responsibility for high volume

electronic products. Motorola has provided many opportunities to investigate product and supplier quality. I consider myself an expert at identifying root

causes, and resolving. Based on the similarities of ISO/TL 9001 to ISO 13485 and the FDA 21 CFR 820, I am confident in making an easy transition to the

medical device QMS.

Working as a Raytheon Senior Systems Engineer, I collaborated with multiple teams collecting requirements, performing risk analysis, and

developing schedules, to develop robust products. My Lucent/Bell Laboratory days, gave me a broad knowledge of product design/development and

fabrication, lean manufacturing and testing. My professionalism and combined skills would allow me to immediately deliver the required results. I have

managed teams, and know how to create an enthusiastic working environment. A highlighted listing of my experiences is given below.

Medical device background

Tufts University, 2004 Bioengineering Certificate (GPA 3.8/4.0)

Human Physiology

Design of Medical Devices

Principles of Medical Imaging

Bioengineering Materials

Recent general readings/interests

ISO 13485

IQ/OQ/PQ process validations for QMS

cGMP

FDA QSR 21 CFR 820 ( 510K/PMA)

Class I/II/III med. devices

Service and Quality experience

MOL (Maintenance of Line) Regularly interface with factory personnel in China

High volume electronic manufacturing

DOE

Lead engineer responsible for FACTORY qualification (due to multiple products (entire product line) being transferred in China)

Directs mechanical sustaining and service teams’ efforts at two facilities, located in MA.

Compliance Manager (high volume telecom product)

Field Engineering Mgr (installation of telecom equipment)

Direct interface with vendors to determine root causes of defects

China, Taiwan, USA

Set AQL for components based on defect trends and lot sizes

Customer interface for all ECRs (Engineering Change Requests). Liaison to customer to resolve critical product reliability and serviceability issues.

Costing, Scheduling, Risk Analysis/Trade studies/FMEA

Change Control Board (CCB)(Chair-person of team)

Material Disposition, Part qualification

WDA---Warranty Data

Data analysis to drill deep into repair issues, identify trends, and resolve.

Motorola Six Sigma DMAIC Green Belt, 2008

Regular user of Minitab

SPC, Cp, Cpk, AQL, DOE

EFAs (Chair-person of team)

Multiple component/part qualifications (able to provide many examples/documents)

Supply Chain point-of-contact for EOL components and prototypes

Fabrication and evaluation of materials, components, devices, test fixtures and prototypes

Plastics---molding, extrusions, general properties

Metals---casting, fabrication, extrusions, properties

NPI---Design/Development

PRO/Engineer, Windchill

Compliance/ Regulatory & Safety Testing (Telcordia, UL, NEBS, CE, CSA, ETSI, FCC, RoHS)

FAIs

DVTs (able to provide many examples/documents)

FMEA/CAPA

Established/created a test report templates and standards used throughout the Sustain Engineering Department

Board Modification History (BMH) document

DVT and Quality investigations template

FAI standard template

Participated in TL9000 Audit

I am enthusiastic about obtaining employment in the medical device/health industry. I am confident in my abilities to immediately perform this

function at a high level. Yes, I have not worked directly in the medical field before, but I have accepted mechanical responsibility of three (3) completely

different product lines, in the past six (6) years. My bioengineering studies at Tufts University prove my aptitude and desire to excel at new disciplines. I am

ready to make a positive impact for the team. My engineering and managing background, especially in the sustaining, quality and manufacturing fields, makes

me a strong candidate for this position. I would welcome the opportunity to discuss my qualifications for this position in more depth with your team.

Thank you in advance.

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