Engineer Mechanical Engineering
Resume:
JOSEPH ZAKRZEWSKI (pronounced: zock-chef'-skee)
**** ******* **** *****, *************, GA 30044
*******@*****.***
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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