Engineer Medical Device
Resume:
Title:Control Specialist
abpgek@r.postjobfree.com
Document
Source below
NAME:,
ADDRESS:
ADDRESS2:
CITY:
STATE: NJ
ZIP:
CANDIDATE ID: 2907767
US CITIZENSHIP:
EDUCATION:
EXPERIENCE: 0
WILL RELOCATE: No -
JOB WANTED:
RATE NEEDED:
TELEPHONE: 732-***-****
EMAIL: abpgek@r.postjobfree.com
HOMEPAGE:
HOTTEST SKILLS: product, medical, injection, mold, brand, market, strategic, bacteria,
glucose, laboratory, membrane, organic, pharmaceutical, sterilization, audit, journal,
liability
REVISION: 08-SEP-02
RESUME:
NAME: GREGORY SKURKA
ADDRESS: 28 BELMONT AVENUE
CITY: OLD BRIDGE
STATE/PROVINCE: NJ
ZIP/POSTAL CODE:
COUNTRY: USA
EMAIL:
PHONE: 732-***-****
CANDIDATE ID: NA
CITIZENSHIP: US
Citizen
EDUCATION: Not Entered
EXPERIENCE: Not Entered
WILL RELOCATE: Not Entered
RELOCATION INFO: Not Entered
JOB WANTED: Any
RATE NEEDED: Not Entered
HOMEPAGE:
COMMENTS:
HOTSKILLS:
GREGORY R. SKURKA
28 BELMONT AVENUE
OLD BRIDGE, NJ 08857-1121
(F)
abpgek@r.postjobfree.com
SUMMARY
Senior Staff Engineer and principal team member responsible for design
and implementation of $20+ million facility for aseptic production and
packaging of pre-filled syringes. Over 15 years demonstrated Project
Leadership and Engineering experience with strategic manufacturing
automation programs in world-class manufacturing environments.
Thorough working knowledge of state-of-the-art industrial automation
applied to medical device manufacturing, high-speed packaging, machine
vision inspection, automatic assembly, converting, narrow-web
printing, laminating, material handling and conveying equipment.
Skilled in employing robotics, and hard automation consistent with FDA
medical device GMP requirements. Ability to work effectively with
internal/external vendors, technical/executive staff and unionized
crafts to achieve demanding business results. Project leadership
required extensive domestic and international travel to equipment
suppliers. Familiar with AutoCAD, MS Project and MS Office.
RELATED EXPERIENCE
SENIOR STAFF ENGINEER
1994-PresentSOLOPAKPHARMACEUTICALS, Elk Grove
Village, IL
Led team to redesign existing syringe for automated assembly achieving
robust "parameter design" performance through the application of
Taguchi methods. Patent Pending on design.
Prototyped and scaled-up injection molding operation for new syringe
design.
Implemented and validated automated syringe inspection, labeling and
packaging system to substantially reduce production costs and
packaging source reduction.
Prepared necessary engineering detail for 510K submission and
Pre-production Quality Assurance (PPQA) documents.
Implemented printing and labeling operation for prefilled syringe
device.
Assembled necessary contract engineering and validation resources to
support syringe automation project.
Support existing base business of syringe, vial, production and
primary injection molding operation.
PROCESS ENGINEER
1992-1993LIFESCAN, a Johnson & Johnson Company,
Milpitas, CA
Team member to develop new reagent test strip for diabetes glucose
management (Class II medical device).
Fast cycle project management approach.
Membrane laminate material development.
Concept manufacturing and packaging methods.
Process specifications.
Standard Operating Procedures - SOP's.
Qualify and validate equipment.
Manage equipment suppliers of FFS inert gas packaging machinery.
Automate reagent strip pick-and-place devices.
Drop-on-demand type date coding.
Machine vision inspection.
Clean-room environment.
Developed test method for measuring residual oxygen in packaged
reagent test strips.
Conducted vendor/supplier audits.
PROJECT ENGINEER
1990-1992JOHNSON & JOHNSON Consumer Products, North
Brunswick, NJ
Provided project leadership in the design, fabrication and
installation of new medical tape packaging line and engineering
support for plant closing in Illinois. Supervised 5 engineers.
Led project team that conceptualized, designed, acquired, and
implemented new $1.3 million medical tape slitting and packaging
operation that doubled production capacity, reduced changeover time 8
fold, and reduced export goods packaging costs $100,000 annually.
Key project team member responsible for closing Illinois plant and
relocating manufacturing operations to Kentucky and New Jersey on
schedule, within cost objectives, and with no adverse customer impact.
Designed a laser date coding system for plastic medical tape
dispensers that was featured in a packaging trade journal.
Applied ergonomic principles and utilized proprietary graphite epoxy
composites in designing and implementing an improved tape rewinding
mandrel that reduced maintenance costs, operator fatigue and mitigated
repetitive trauma disorder (RTD) concerns.
ENGINEER
1987-1990JOHNSON & JOHNSON Consumer Products, North
Brunswick, NJ
Designed proprietary high-speed, multi-component collating and
packaging device for adhesive bandages subsequently scaled-up for
commercial production of all domestic product volume.
Concepted, specified and implemented new flexible six-axis robotic
material handling system that achieved 98% reliability in production
and cost savings of $300,000 annually per work cell.
Developed high-speed dynamically balanced reciprocating knife for
proprietary adhesive bandage cutting/collating device that improved
predictive maintenance capability.
Designed and developed laminating and material handling/packaging
system for new specialty adhesive bandage put-up to meet customer
needs.
ASSOCIATE ENGINEER
1981-1987JOHNSON & JOHNSON Consumer Products in
Chicago, IL; Las Piedras, PR; North Brunswick, NJ; and Sherman, TX.
Project leader responsible for successfully redesigning, developing
and installing automated consumer tape equipment modification and
upgrades in a new $20 million operation to meet machine productivity
objectives.
Savings increased $250,000 annually on case packing and palletizing
operation.
Modified bottle-filling equipment for wound-care dressing products.
Developed automated dental floss dispenser assembly equipment.
Supported installation, development, and qualification of automated
European and domestic converting and packaging machinery that
contributed to successful introduction of three new sterile woven and
non-woven gauze products in professional and consumer markets.
Investigated gamma ray and EtO sterilization of gauze products.
Installed equipment for packaging Surgicel(r) Absorbable Hemostat in a
Class 10,000 clean room environment.
Assisted in development of automated high-speed packaging system for
Band-Aid(r) Brand Adhesive Bandages.
Modified adhesive bandage laminating equipment for new hemostatic and
anti-bacterial products.
Implemented recirculating type ink-jet date coding equipment.
Assisted in design of a proprietary automated tape slitter.
ENGINEERING TECHNICIAN
1976-1978INGERSOLL-RAND RESEARCH, INC.,
Princeton, NJ
Developed automated coal mining equipment. Performance-tested turbo
machinery. Conducted stress and strain analyses. Performed
metallurgical laboratory tests and authored reports.
EDUCATION
May 1994
New Jersey Institute of TechnologyNewark, NJ BS, Mechanical
Engineering
degree requirements completed
May 1977
Middlesex County CollegeEdison, NJ A.A.S., Mechanical
Engineering Technology
INTERESTS
Private pilot, SEL; alpine skiing, motor cycling, home improvements,
organic gardening and automobile restoration.
Contact this candidate