JOSEPH ZAKRZEWSKI (pronounced: zock-chef'-skee)

**** ******* **** *****, *************, GA 30044

acfscj@r.postjobfree.com

205-***-****

Over 15 years of experience in new product/process research and development

including Fortune 500 companies and pilot plants. Demonstrated record of

success in leading development of FDA regulated products from concept to

manufacturing, and mature products through next generation improvements and

line extensions. Key strengths: R&D, validation, clinical trials,

statistical optimization / cost reduction, Black Belt six sigma, creativity

and robustness in engineering, and cross functional team leadership.

PROFESSIONAL EXPERIENCE

IMMUCOR GAMMA, INC., Atlanta, GA 2012 - 14

Process / Validation Engineer

. Lead bulk manufacture and processing of blood typing reagents

> Baselined then optimized processes, implemented Continuous

Improvement, Lean and Value Stream Mapping, realizing savings of

$584k/year

. Qualified blood reagent test kit for market release

> Authored/executed process characterizations, gap analyses and

validations

> Conducted Process/Risk Assessments, Safety Reviews.

. Investigated/Audited supplier quality issues, led CAPAs and

redesigns of components

. Troubleshot and optimized formulation process, reducing mixing time

50% and maintaining potency 4 times as long.

ST. JUDE MEDICAL, Hackettstown, NJ 2011 - 12

Senior Validation Engineer (Consultant)

Project Leader of validations of Class III spinal-implant medical

device testing systems.

. Performed Test Method Validation of six new systems, doubling

production capacity

> Authored and executed IQ/OQ/PQ, created work instructions,

calibration procedures

> Conducted Gage R&R and Risk Assessment / PFMEA

BECTON, DICKINSON & CO. (BD), Franklin Lakes, NJ 2005 - 11

Project Leader (2008-2011) / Senior Engineer (2005-2008)

Lead R&D team member for new products, processes and sterilization

methods in acquisition and containment devices, including high volume

manufacturing and chemical additive processing. Author of

specifications; led line extensions and market expansions.

. Utilized Design for Six Sigma (DFSS) techniques in product/process

design

> Gage R&R, MSA, DOE, Voice of Customer, House of Quality, FMEA

. Led teams researching and validating alternate materials for

components, maintaining production and lowering resin cost 30%

. Conducted successful feasibility trial for system to modulate blood

draw pressure, preventing fragile vein collapse

. Led Design Control team, lead Design History File (DHF) auditor

PROCTER & GAMBLE (PG), [Songbird Hearing, Inc.] Princeton, NJ 2002 -

05

Process / Product Development Engineer

Lead process engineer for high volume, automation manufacture of

world's first disposable hearing aid, an FDA/ISO/CE regulated Class II

medical device made in GMP environment.

JOSEPH ZAKRZEWSKI (page 2)

Managed SOPs, MARs, CAPAs, Supplier Quality. Executed Installation,

Operational, and Performance/ Process Qualifications (IQ/OQ/PQ).

. Designed and developed an OTC disposable hearing aid. Clinical study

liaison, collaborating with audiologists and marketing

. Developed PLC and HMI layouts for production, reducing changeover

time 90%

. Project management (of task/result):

> Designed and implemented wax guard / Reducing impaction failures

99%

> Optimized injection molded casing / Mechanical stress failure

eliminated

> Developed process/equipment for closure assembly / Reducing cycle

time 75%

INTERNATIONAL BUSINESS MACHINES (IBM), Burlington, VT 2001-02

Process Engineer

Led wet etch/clean sector of semiconductor fabrication line. Supervised

a four person team in process and tooling aspects of manufacturing

operations. Ensured quality of processes using cGMP, Statistical Data

Analysis, SPC, QSR, and Sampling Plans. Specified and validated new

electromechanical equipment and processes. Maintained EPA, OSHA,

Federal and State regulations compliance.

. Optimized placement of cleans to reduce defects 20% and raise yield

1%

. Ensured constant production; investigated nonconforming processes

using Root Cause Analysis, Design of Experiments, Failure Mode and

Effects Analysis. Authored Corrective and Preventative Actions.

STRYKER (ORTHOVITA, INC.), Malvern, PA 2000-01

Product Development Engineer

Proposed, designed, and developed new orthopedic medical equipment and

instrumentation for use with osteoinductive bone void fillers

. Modeled and tested spinal inter-body fusion device prototypes using

PRO-E, FEA, market feasibility studies. Collaborated with surgeons,

product managers, and external design firms in device production.

. Initiated and maintained database of Engineering Drawings, Device

Specifications, and Statements of Operational Requirements to

improve traceability.

EDUCATION

M.S., Mechanical Engineering / B.S., Mechanical Engineering (Magna Cum

Laude)

Drexel University, Philadelphia, PA

CERTIFICATIONS / TRAINING

Engineer in Training / Fundamentals of Engineering (EIT / FE) Certified

Critical Parameter Management (CPM) Practitioner

Black Belt Six Sigma DMAIC, Trained in DFSS / LEAN

TECHNICAL SKILLS

Minitab / DOE / SPC Technical Writing Pro/ENGINEER

Root Cause Investigation SolidWorks PLC

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