Engineering Manager Chemical

Edward J. Lombardi

** ******** ****, ***** *** Hampshire 03038

Home 1-603-***-**** Cell 1-603-***-****

e-mail - ***************@*****.***

Objective

Utilize my experience and skills in R & D to construct and bring new medical devices to the market. I sometimes use typical or unconventional approaches but thrive on outside the box concepts.

Qualifications

Accomplished Engineer with over 40 years of significant experience in medical devices. Background includes developing new medical devices patented in the USA as well as globally. Have demonstrated proven leadership skills managing projects, developing medical products from conception through release, cost control, patent processes and technical evaluations.

Education

BS Chemical Engineering – Northeastern University

Professional Experience

Opportunity / Discovery 2013 - 2022

Started as CEO, O/D, an LLC to bring medical devices to the market.

Hired a CEO to operate business.

As CTO, Developed and patented a disposable sheath for endoscopes.

Acquired a Word Wide Patent on the device.

Product eliminates the transfer of viruses and bacteria from patient to patient. Increases patient turnaround times, reduced cleaning time, fits all marketed scopes.

Consultations: 2008 - Present

Arrow / Teleflex

Assess processes to improve IAB manufacturing and efficiencies.

Developed a dipping safety mechanism to prevent equipment damage.

Revised mfg.& acceptance procedures increasing product acceptance from 32% to 68%.

Enable Injection

Develop a disposable device that when inserted via a needle into a vial it inflates and dispenses a therapeutic drug.

CSF Therapeutics, Inc.

Development of a Neuro Oxygenation Device to Assist Patients.

NT Medical

Develop Medical Devices/Processes that meet customer requirements.

oVarious Catheters for custom use

oCustom fabricated obesity balloon

oColonoscopy Balloon Isolation Device

oAortic Aneurism Isolation Device

oThoracotomy Device.

oCustom Intibator Bellows.

oForce distribution Foot Pads

oBio-compatible Coatings

oEsophageal Balloon

Update NT Medical Quality System to meet regulatory requirements.

Teleflex Medical 2007 - 2008

R & D Engineering Manager for disposable products

Manage individuals in the development of new products.

Develop new medical device concepts.

Develop a bio compatible coating for Nano Devices.

Provide expertise to mfg. in the development of current and new devices.

Review / approve all changes applicable in mfg disposable devices.

Develop / approve test equipment to support the mfg disposable devices.

Arrow International 1994 - 2007

Manufacturing / R & D Engineering Manager for IABs / disposable products

Manage all engineering aspects for IAB mfg. and R & D.

Develop new medical devices.

Accomplishments

Develop the first IAB wire wrap design.

Develop the first fiber optic IAB.

Acquisitions resulted in the transfer of Boston Scientific and Bard IAB mfg. operations to Arrow.

Consolidated best features of the Arrow, Boston Scientific and Bard IAB designs into Arrow’s current IAB product line.

Kontron Instruments Inc. 1985 - 1994

Manufacturing / R & D Engineering Manager for IABs / disposable products

Manage all engineering aspects for IAB mfg. and R & D.

Develop new medical devices.

Accomplishments

Develop next generation of IABs.

Develop a new process for insertion of IABs.

Design angioplasty / valvulaplasty product line.

Develop and enhanced PBP product.

Develop various internal and external heart assist devices.

Develop various right heart assist devices.

Develop a liquid extrusion process for coating catheters.

Develop 2nd generation line of ECMO catheter products and mfg.

Develop and enhanced hemostasis sheath.

Teleflex (Teleflex Medical / Aries Medical) 1980 - 1985

Start up company

Develop a complete line of IAB products for Teleflex.

Responsible for R & D, Engineering, Manufacturing and other functions.

Developed and qualified the release of Teleflex’s IAB product line.

Accomplishments

Develop a navigation device for an Endoscope after insertion into the large intestine.

Develop and patented a hemostasis sheath for use with IAB products.

Develop and patented the first torque tube catheter for use with IABs.

Provide expertise in the development Teleflex’s extrusion process.

Kontron Instruments Inc. 1979 - 1980

Development Engineer

Develop new IAB products and devices.

Prototype devices requested by physicians

Accomplishments

Develop new IAB designs and devices aid insertion processes.

Design angioplasty / valvulaplasty product line.

Develop various internal and external right and left heart assist devices.

Develop a pediatric disposable monitoring device (Fetal Electrode).

Develop ECMO catheter devices.

Develop various right heart assist devices.

Investigate a liquid extrusion process for coating catheters.

Develop and mfg. ECMO catheter line.

Avco Research Labs 1975 - 1979

Development Engineer

Develop new IAB products and devices.

Prototype devices requested by physicians

Accomplishments

Developed the First Flexible Tip IAB Device

Develop IABs, intracranial pressure device, PBP, angioplasty / valvulaplasty products, a device that without trauma can dilate the vaginal cavity.

Assist in the development of a Total Heart.

Develop processes navigation and mfg. ECMO wire wrapped catheters.

Assist in the development of various right heart assist devices.

Patents:

USRE34993

Method of inserting an lAB device into the body

US5254090

Balloon catheter having a dual layer inner member

EP0567549A1

DURABLE AND FLEXIBLE CATHETER OR CENTRAL LUMEN HAVING A LOW KINK RADIUS

US5120299

Intra-aortic balloon assembly with hemostasis device

US4897077

Method of inserting an IAB device into the body

EP0256683A3

Means for furling a balloon of a balloon catheter

EP0256683A2

Means for furling a balloon of a balloon catheter

US4646719

Intra-aortic balloon catheter having flexible torque transmitting tube

DE3368504C0

FETAL ELECTRODE APPARATUS

EP0182905A1

INTRA-AORTIC BALLOON CATHETER HAVING FLEXIBLE TORQUE TRANSMITTING TUBE

EP0099077B1

Fetal electrode apparatus

US4501276

Fetal electrode apparatus

EP0047465B1

Percutaneous balloon catheter

DE3171487C0

PERCUTANEOUS BALLOON CATHETER

EP0099077A3

Fetal electrode apparatus

EP0099077A2

Fetal electrode apparatus

US4362150

Percutaneous intra-aortic balloon apparatus

EP0047465A1

Percutaneous balloon catheter

EP0265864A3

Hemostasis sheath

EP0265864A2

Hemostasis sheath

EP0265864B1

Hemostasis sheath

US9,498,109

Endoscopic Sheath

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