MICHAEL J. CUPICHA
25 Hy Drive * East Schodack, NY 12063
[Send email to request phone number] 75-1543 *
Hands-on Technical Leader and Principal Engineer with a proven ability to take
major programs from concept to final, successful implementation while optimizing
processes at each step. A leader and mentor of productive teams achieving
Corporate and Divisional Goals. Creative problem solver able to draw upon his own
and the teams' expertise to find the best solutions. Dedicated to LEAN and Six
Sigma principles for continuous improvement and quality. Holder of and
contributor to multiple patents. Deep engineering knowledge in medical, consumer,
safety and automotive industries. ISO 13485, FDA Class I, II and III medical
experience.
* Project Management
* Certified Six Sigma BLACK BELT
* SolidWorks, AutoCad
* Product Design, NPI
* Certified Six Sigma LEAN
* Manufacturing Engineering
* Business Systems and Contracts
* Supply Chain Negotiations
* International Business/ Sales Support
* Quality Assurance/Control
* FDA 510k / ISO 13485 / CE
* Toyota Production System
PATENTS AND PUBLICATIONS
US Patent #D567937 (nonwovens); Canadian Patent # CA 1208896 (chemical);
US Application # 20080178884 (plastics); Mexico Application of # 2005020380 US
(nonwovens)
Publication: UK ISSN # 0141-8246: Vapor Fumes
PROFESSIONAL EXPERIENCE
Mini-Lab Technologies, Dobbs Ferry, NY (FDA) 2009 - Present
Engineer
Direct engineering aspects of product design for numerous products including:
* Developed an innovative Saphenous vein, venous ulcer compression wound
dressing design under FDA design controls, DHF, DFMEA, PFMEA (Class II). Utilized
SolidWorks to design the device, selected relevant materials for fibers, mesh,
weaves, polyurethanes, valving, pumps and packaging. Successfully completed test
and design for biocompatibility, skin-irritation and gamma sterilization. First
Articles.
* Prototyped a liver retraction device in LIM Silicone with design of insertion
and retraction thru a 12mm surgical port.
* Provided Advanced, 6 Sigma Manufacturing Engineering support for laparoscopic
surgical device manufacture.
Key Accomplishments:
* Initiated and managed numerous lean initiatives, streamlining process maps
and implementing quick-change over programs to enhance efficiencies in the
clean-room assembly environment.
* Developed numerous, new medical device concepts from initial design to First
Article.
* Authored innovative test protocols and relevant SOPs under ISO 13485, IQ, OQ,
PQs.
Clinetics; e-engineering, New York, NY (FDA) 2008 - 2009
Principal Engineer
Led engineering for medical products, FDA 510k submissions and NIOSH approvals
to international companies, primarily in Asia. Projects included:
* Designed a successful medical TB device for a manufacturer in China.
* Performed conceptual design engineering for an automated filter assembly
machine going to India, with final equipment sourcing and build through Taiwan.
Key Accomplishments:
* Change Agent/Six Sigma Champion for corporate programs resulting in OEE of
97%, and Cpk]2.0.
* Developed an innovative surgical mask design that reduced scrap / waste by
75%.
Insulet Corporation, Bedford, MA (FDA, ISO) 2007 - 2008
Senior Manufacturing Engineer
Drove quality and scheduling for, and contributed to the engineering of the
final design, debug and implementation of a multi-million dollar high-speed
automatic cannula, catheter and needle assembly machine for automatic insulin
injection devices. Implemented high-speed assembly of a small catheter with
related pressurized testing of the medical device and automatic vision system
checking Major A dimensions. Led specific project components including:
* Developed concepts for tubing feeders, needle holding, mandrel cooling,
pressure testing & vibratory feeding.
* Performed FAT, SAT, IQ, OQ, PQ validations/verifications on the catheter
automatic equipment.
* Reviewed biocompatibility testing and analysis of the equipment, cannula and
needle fluid processing aids.
Key Accomplishments:
* Achieved final Six Sigma Lean / OEE acceptance of the automated equipment at
95%.
* Authored FMEAs, risk analysis, mitigations and process mapping.
* Drove and met aggressive engineering and design timeline using project
management skills.
* Successfully implemented a 54 station automatic catheter machine into the
factory resulting in annual savings of approximately $2 million.
Gerson Company, Middleboro, MA (FDA, Pre-ISO) 2003 - 2007
Engineer, Consulting
Led engineering excellence and process improvements for the design and
installation of high-speed specialty equipment, including continuous, non-woven
filtration feeding and cutting lines coupled with ultrasonic assembly. Negotiated
International Business Contracts and provided on-site engineering expertise for
facilities in China, Mexico and Canada, including group employee training
sessions in quality and Six Sigma.
Key Accomplishments:
* Awarded several patents for the design and development of a new respirator,
provided lab and prototype development, wrote the FDA 510k and launched the
device on new, automated equipment.
* Served as resident expert for ultrasonic sealing and forming of plastics and
nonwovens.
* Designed new filtration disposable products passing NIOSH and Class I, Class
II FDA regulations under 21 CFR.820 Design Controls, receiving final FDA and
NIOSH/CE mark approvals.
* Selected to and performed responsibilities as Chairperson for Company-wide
Design Reviews.
* Trained Chinese workers on and conducted LEAN / Kaizen Events, DOE that
improved production by 45% on new non-woven equipment in China by comparing rotor
r.p.m. vs. ultrasonic welding % power.
* 5S program successfully implemented.
East Coast Respiratory; Watervliet, NY (FDA Registered) 1995 - 2003
Senior Principal Engineer
Led design and engineering for multiple product commercialization projects using
rotary die cutting for films and non-wovens, as well as silicone liquid injection
molding and custom plastic molding to meet FDA requirements. Oversaw and provided
hands-on engineering expertise for materials development; product design; and
equipment and tooling selection and installation. Managed the NPD Design Control,
Design History File, and Stage Gate Program Management of projects. Conducted
non-woven and rigid plastics research, engineering, Products and Sales support
and Contract Negotiations into Kimberly-Clark, Playtex, National Veteran's
Administration, Toshiba, Evenflo, and the First Years. Improved the Supply Chain
for crucial components by utilizing JIT techniques.
Key Accomplishments:
* Provided critical engineering design input for the development and launch of
a new nursing pad with lanolin requiring complex manufacturing design related to
elevated temperature lanolin applications. Further enhanced production by
developing an automatic pad line using ultrasonics and rotary die cutting
techniques while changing the process map into a manufacturing cell. Customer
awarded Patent.
* Conducted ACTS product testing for consumer safety. Coordinated and
interacted with Doctor/ Parent/ Consumer Test Panels on products for input
re-designs under Stage Gate controls. Reviewed human and animal clinical trials
and made final recommendations.
* Developed and sold internationally; NIOSH N95, N99, European FFP1, P2
respirators, TB medical respirators approved by NIOSH, CE, JA, AS, CN, EN, and
FDA regulatory bodies.
* Authored new equipment specifications, tooling design, build and
installations, SOP sheets, clean room procedures; and provided LEAN, Kaizen
training to production teams that ultimately improved operations.
EDUCATION AND TECHNICAL TRAINING
BS, Management (Industrial) - Rensselaer Polytechnic Institute, Troy, NY
ISO, Plastics Design, Tool Design, Advanced Equipment Design, Program
Management, Finite Element, SMED/ Quick tool change, Team training, Medical
Devices, Toyota Quality, Ford Q1 Quality, Taguchi, Cells, Lean Certified, Six
Sigma Black Belt Certified, Air Particle Measurement, TSI Instrumentation,
Respirator Fit Testing
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