Engineer Project Manager
Resume:
Marc-Alan Levine
Marc-Alan Levine
**** ***** ****** ****, *********, PA 19465
(H) 610-***-**** (C) 415-***-****
abnkq6@r.postjobfree.com
PROFESSIONAL PROFILE:
Eighteen years experience in design, development and manufacturing of class I, class II and class III in-vitro diagnostic,
therapeutic, and neurological medical devices and instruments with proven leadership skills. Ability to successfully manage
key projects, direct reports and cross-functional project teams to achieve company goals. Experience presenting to executive
management and representing the company with high profile surgeons, clinicians, customers and regulatory authorities.
SUMMARY OF QUALIFICATIONS:
• Comprehensive understanding of the development and marketing process for Medical Devices marketed worldwide
• Ability to organize, plan, and manage complex development programs
• Strong Quality, Regulatory, and Manufacturing Background including knowledge of Quality System Regulations, ISO
9001 and 13485:2003
• High degree of problem solving skills, ability to decipher the root cause of problems and come up with unique
engineering solutions.
• Developed analytical models to comparatively evaluate product performance.
• Designing of complex products comprised of plastics and metals (including Nitinol, Stainless Steel)
• Successfully management of outside vendors to ensure products are manufactured with the highest quality and delivered
on time
• Perform patent reviews for freedom to operate and to determine unique intellectual property
• Excellent communication skills
CAREER ACHIEVEMENTS:
• Successfully managed the development of products from concept to clinical use/commercialization (Class I, II, and III
Medical devices) in support of corporate objectives
• Co-inventor of twenty US Patents
• Managed development programs for 510(k) products and IDE/PMA studies.
• Direct OR experience in Neurological and Cardiovascular procedures
EXPERIENCE:
Bay Street Medical Incorporated Pottstown PA and Mountain View, CA
2006 – Present Sr. Principal Engineer
Company is developing self expanding stent for both the cardiovascular and neurovascular market.
Evaluation of new technologies for both current product line and future projects
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Responsible for development of guidewire based nitinol stent delivery system
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Mechanical testing and evaluation of delivery system, fatigue analysis of nitinol stent
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Coordinated the outsourcing for the complete product line from raw material to finished product
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with vendors.
Responsible for the documentation system used by the company.
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New business development
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Intellectual Property management
•
2005- 2008 Engineering Consultant Pottstown PA
Provided project management, prototype development and acute animal studies for various companies
Designed various vascular bio- absorbable anastamotic couplers and evaluated technologies for use
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as sealants for microsurgery applications
Developed and evaluated mechanical clot lysing technology with physicians, sold to Micrus
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Endovascular 2007
Marc-Alan Levine
VascularFX LLC
2003- 2005 Sr. Principal Engineer Pottstown PA and and Palo Alto, CA
Company developed a steerable catheter platform, infusion catheter, ptca and soft compliant balloon
catheter.
Responsible for project management and development of steerable catheter product line
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Intellectual Property management
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Developed new microcatheter construction technologies and techniques that were transferred to
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vendors for buildup of product
Developed product specification and criteria for evaluation by interfacing with physicians to
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understand end user requirements
Responsible for mechanical testing and evaluation of product at various stages of development,
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both In-Vitro and In-Vivo.
Coordinated product builds with outside vendors
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Project sold to Micrus Endovascular summer of 2005
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Transferred product line, manufacturing and R&D to Micrus Endovascular
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Rex Medical Conshohocken, PA
2002 - 2003 Project Engineer
An ISO 9001 company specializing in the development, manufacturing, and marketing of innovative,
minimally invasive medical devices in the cardiovascular, venous access, endosurgery, and oncology
markets.
Manage innovative Medical Device Programs for the cardiovascular market.
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Responsible for all aspects of product development including documentation, design control,
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quality control, coordination of regulatory testing and submissions, and participation in legal
reviews.
Manage user comprehension, product simulation, animal, including protocol and report
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generation, marketing evaluations, and data analysis
Perform literature searches, competitive product analysis, and marketing and field research with
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local hospitals and surgeons to generate new ideas and concepts for emerging market needs, as
well as identify new or improved product ideas.
Manage, perform, and review risk management for new products
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Evaluate and qualify vendors for contract manufacturing.
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Counter Clockwise Incorporated
CEO Founder
2000 – 2002 San Francisco, CA
Company developed tools for the interventional neurovascular surgeon and cardiologist. IP later
licensed to VascularFX and Bay Street Medical.
Fund raising
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New business development
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Intellectual property management, and generation
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Engineering duties including design, development and project planning
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Smart Therapeutics Incorporated
R&D Engineer
1999 – 2000 San Leandro, CA
Company developed first self expanding stent used in the neurovasculature. Acquired by Boston
Scientific.
Responsible for the specification and design of the delivery system for the neurovascular stent.
•
Developed manufacturing methods and procedures for the components to the delivery system
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made in house.
Part of the team that developed the quality system used by the company
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Instrumental in pre-clinical builds and manufacturing outsourcing of key components
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Marc-Alan Levine
Responsible for In-Vivo GLP study used for HDPE filing.
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Generated manufacturing documentation for in-house components of delivery system
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Endovasix Incorporated
R&D Engineer
1997 – 1999 Belmont, CA
Company developed a photo acoustic ablation device used to break up clot in the neurovasculature.
Project manager including specification and design of a 1 French laser based clot lysing system
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Part of the team that developed the 3 French device.
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Managed manufacturing builds used in pre-clinical and clinical evaluations.
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Managed the clean room and personal.
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Responsible for generating Manufacturing and Quality procedures and tests.
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Company representative (on site) for 5 month clinical trials both in the United States and Europe.
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Target Therapeutics Incorporated
R&D Engineer
1996 – 1997 Fremont, CA
Company developed products to treat neurovascular disease, acquired by Boston Scientific.
Developed neurovascular coil retrieval system, marketed as the Attractor 18
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Developed new coil designs for aneurysm repair, marketed as the 3D GDC
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Responsible for pre- clinical study used for 510K submission of the neurovascular retrieval system.
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Developed fixtures used in manufacturing for the 3D coils.
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Researched and developed a In-Vitro aneurysm model to study coil compaction due to
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intravascular pressure and blood hemodynamics.
Focal Incorporated
Design Engineer
1994 – 1996 Lexington, Mass
Company developed plastic stents and hyrodgels used for localized drug delivery, acquired by
Genzyme.
Developed instruments for laproscopic surgery for lung repair.
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Developed device to measure the coefficient of friction on bioabsorbable implants with coatings.
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Developed device to simulate shear rate of arterial blood flow on implants for evaluation of
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coatings.
Performed general machine shop duties
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Responsible for product testing protocols, materials and final reports.
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Acufex Microsurgical Incorporated
Associate Development Engineer
1991 – 1993 Mansfield, Mass
Company developed metallic and bioabsorbable fixation devices for bone repair.
Designed instruments used in delivering existing bone fixation devices
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Responsible for Process/Product validation procedure and protocols
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Managed department network/computers, including troubleshooting software compatibility and
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customizing software applications
Directed activities and provided general supervision-guidance to cooperative education students.
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Marc-Alan Levine
EDUCATION: Bachelor of Science, Mechanical Engineering Technology
Northeastern University, Boston MA
1990
PATENTS & PUBLICATIONS:
• 5,749,968 Device for Priming for Improved Adherence of Gels to Substrate
• 5,800,373 Initiator Priming for Improved Adherence of Gels to Substrate
• 5,868,754 Medical Retrieval Device
• 6,074,407 Delivery Catheter for Occlusive Implants
• 6,121,341 Redox Photoinitiator System for Priming and Improved Adherence
• 6,139,543 Flow Apparatus for the Disruption of Occlusions
• 6,210,400 Flexible Flow Apparatus and Method for Disruption of Occlusions
• 6,322,576 Stable Coil Designs
• 6,387,977 Redox Photoinitiator System for Priming and Improved Adherence
• 6,482,221 Maniputable Delivery Catheter for Occlusive Devices (II)
• 6,547,779 Flexible Flow Apparatus and Method for Disruption of Occlusions
• 6,726,700 Maniputable Delivery Catheter for Occlusive Devices
• 6,793,667 Maniputable Delivery Catheter for Occlusive Devices (II)
• 6,860,893 Stable Coil Designs
• 6,989,024 Guidewire Loaded Stent for Delivery Through a Catheter
• 6,976,991 Maniputable Delivery Catheter for Occlusive Devices (LL)
• 7,137,990 Maniputable Delivery Catheter for Occlusive Devices (II)
• 7,169,172 Method and Apparatus for Caged Stent Delivery
• 7,300,460 Bifurcated Guidewire and Methods of Use
• 7,331,976 Distal Protection Device
• 7,591,813 Long Nose Maniputable Catheter
Other US and Foreign patents pending
Moody E.W., Levine M.A., Rudowsky, R. and Sawhney A.S., “A Synthetic
Photopolymerized Biodegradable Hydrogel for Sealing Arterial Leaks”, 1996 Fifth
World Biomaterials Congress, Metro Toronto Convention Centre, May 29 – June 2 1996,
Toronto, Canada
J.I. Molho, C- C. Hung, J.G. Santiago, M-A Levine, V. Esch, “Velocity Measurements
and Visualizaitons of the Flow Driven By Laser-Induced Cavitation Bubbles in a Blood-
Like Liquid”, 2000 ASME International Mechanical Engineering Congress and
Exposition (IMECE), November 5 – 10, 2000 Orlando, Florida
SOFTWARE: Autocad, Microsoft Office Suite, including Microsoft Project
REFERENCES: Available upon request
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