Sepehr Fariabi, PhD has 20 years experience in medical device & drug/device combination product development and operation, including 15 years in management positions with increasing levels of responsibility
Candidate believes his greatest strengths include a unique blend of advanced materials, innovation and creativity with expertise in concept-to-launch product development. He also feels his extensive experience in working closely with FDA and European CE regulation personnel to facilitate approval of new products is another key strength, as is his ability to build highly motivated, high-performing teams.
His management style is, according to his co-workers, one of “collaboration with direction,” and he is a direct, clear communicator who has a reputation of “getting things done.” He is accustomed to managing multi-disciplinary teams: biomedical engineering, chemical engineering, mechanical engineering, electrical engineering, materials science, and business analysis.
He was recently functioning as a VP, R&D at Nfocus Neuromedical and SVP for Biosensors
International, where he led the New Product Development efforts for these 25 people start-up medical device company. His charge was to develop Neuro vascular and cardiovascular devices and any associated peripheral systems.
While Candidate has broad expertise in development of cardiovascular, neurovascular, endovascular, and structural heart devices, he has also worked in other disciplines including drug delivery implants, orthopedic (spine, knees, shoulder) probes and IDET instruments, surgical equipment and devices for cataract surgery, cryoplasty therapies, metal and bio-absorbable implants, biomaterials and biotechnologies.
Candidate enjoys an excellent rapport with the various professional societies and was the primary motivator behind the establishment of the Biomedical Devices graduate program at SJSU, Materials and Processes for Medical Devices (MPMD) at ASM, and Frontiers in Biomedical Devices at ASME.
Sepehr was given visiting scientist position for his contribution and collaboration with the cardiovascular research team at Cedars Sinai Medical Center.
SEPEHR FARIABI
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SEPEHR FARIABI, PhD
10 Coastal Canyon Drive, Newport Coast, CA 92657
Cell: 281-797-3078 or 949-726-2846 sfariabi30@gmail.com
PROFESSIONAL OBJECTIVE
Senior management position with focus on leadership, innovative technologies, program management, advanced materials, and operation.
SUMMARY AND SELECTED ACCOMPLISHMENTS
More than 25 years of hands-on leadership experiences in the class-III medical devices with a diverse background in advanced materials, product development, research, regulatory approval, and brining innovative technologies from concept to market release. Well versed in leadership skills to evaluate alternatives, establishing priorities, applying resources effectively, motivate technical staffs, and encourages innovations.
 Extensive experience in advanced materials and early stage product discovery and development, employing a milestone and critical path approach to increasing enterprise value;
 Thorough understanding of both U.S. FDA and European CE regulation processes for Class III devices, including in-vitro and in-vivo test development, protocol development, pre-clinical and clinical testing, and regulatory filing;
 Successfully led the R&D and cross-functional teams in full product life-cycle, from product ideation, concept and development, through to commercialization;
 Grounded in state-of-the-art engineering and manufacturing disciplines, including catheter and stent manufacturing, clean room operations, biocompatibility and sterilization, and packaging development and testing;
 Created highly practical “materials center of excellence” with fully integrated rapid prototyping, alloy development, process development, and testing;
 Holder of more than 30 issued patents. Author of published research in peer-reviewed journals.
EMPLOYMENT HISTORY
IDEV Technologies, Inc., Webster, Texas Director, MANUFACTUIRNG ENGINEERING (08/2010 –Present)
IDEV Technologies is a venture-funded (Raised >$30M) startup medical device company developing a unique interwoven self-expanding nitinol stent system with unmatched flexibility, strength, and fracture resistance.
SUPERA VERITAS
Corrosion Test
 Led R&D and Manufacturing activities related to product biocompatibility and durability testing for CE-Mark and PMA regulatory submissions.
 Led Manufacturing Engineering Team to support R&D product transfer to manufacturing, conducting all process qualification and validation, auditing key suppliers, addressing field issues, and support production with manufacturing issues, cost reduction and yield improvement.
 Responsible for pilot and manufacturing in-house implant passivation development, equipment and facility set-up with more than $250K budget.
 Developed and set-up in-house corrosion (pitting, galvanic, field testing), nickel-ion release, inclusion, and transformation temperatures testing
SEPEHR FARIABI
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Nfocus Neuromedical, Inc., Palo Alto, CA VP, ADVANCED MATERIALS (11/2007 –4/ 2010)
Nfocus Neuromedical is a venture-funded (Raised $20M) startup medical device company developing cerebral aneurysm treatment.
NEC
AES
 Introduced and developed several unique and new proprietary implantable materials including special titanium alloys and fully bioabsorbable polymers;
 Successfully managed and conducted full GLP biocompatibility and chronic animal studies using a special aneurysm model.
 Supported development efforts for several new revolutionary products such as
Neuro Embolization Cover (NEC), Aneurysm Embolization System (AES)
Vascular Occlusion System (VOS), and novel Distal Access Guiding Catheter
 Received 4-CE Marks and 3-US 510(k) regulatory clearances that address $200M
Aneurysm Model of current market needs;
Biosensors International, Newport Beach, CA VP, ENGINEERING (5/2006 –11/ 2007)
Biosensors International is an emerging drug eluting stent company ($500M) with Biolimus BA9 drug. Shift of focus to outside U.S. market resulted in facility shut down in US.
 Led 25 global engineers and scientists experienced from a range of complex polymer, drug and formulation, stability/shelf life, automated coating processes, program management, and testing to meet highly demanding engineering and quality tasks required for regulatory approval of a new fully biodegradable polymeric drug coated stent (DES) delivery system;
 Successfully led the development and operation teams to build 4000 clinical units for new generation DES BioMatrix III and completed all-comers clinical trial with patients enrollment in less than 10 months;
 Successfully developed and brought to FIM the first generation polymer-free DES stent “Bio-Freedom” with a selective micro-structured surface to allow for the drug
 adhesion to the outside surface of the stent without the use of a polymer or binder;
Responsible for product and process transfer to Singapore facility including stent inspection, stent delivery system, drug formulation and automated drug coating process.
Alcon Laboratories, Irvine, California SR. DIRECTOR, INSTRUMENTATION AND CATARACT
RESEARCH (1/2006 – 5/2006)
Alcon Surgical in Irvine is a leader in making cataracts surgical instrumentation.
DES BioMatrix III
 Responsible for Cataract Engineering, Scientific Research, and Engineering Services with more than 60 employees in the group.
 Launched a new patented OZil™ Torsional Handpiece which delivered an enhanced fluidic stability and surgical control. The increased surgical control delivered greater potential for obtaining better surgical outcomes and safety than with traditional phacoemulsification technologies.
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Edwards Lifesciences, Irvine, CA SR. DIRECTOR, R&D (2/2002 – 1/2006)
Edwards Lifesciences ($5.8B) is a leader in advanced cardiovascular disease treatment, the number one heart valve company in the world.
TAV
CS Mitral
Laser HAZ
 Member of company Senior Leadership Team;
 Responsible and mentored a team of more than 35 people to bring three major complexes in nature (breakthrough) programs to FIM level. These programs included
“Transcatheter Aortic Valve (TAVI) ,” “Edge-to-Edge Mitral Valve Repair,” and
“Coronary Sinus Mitral Valve Repair;”
 Took part in acquisition of “Jomed” IP and technology and managed the engineering and operation in Germany;
 Managed all safety and efficacy animal studies for the “Coronary Sinus Mitral Valve” program in Sweden;
 Formed a new advanced materials group to develop and set up a rapid prototyping capability including full materials characterization and testing.
Advanced Stent Technologies (AST), Pleasanton, CA VP, OPERATION (1/2001 – 2/2002)
AST was a private-funded ($40M) start-up medical device company developing bifurcation stent technology.
AST was acquired by Boston Scientific Corp in 2004.
 Hosted the first official meeting of the company and recommended the strategy on product design, location of the company, and hired the key engineering team;
 As an active BOD member of the company, participated in discussion and decision making of key company issues and business strategy;
 Led the operation and fostered team work for AST to be the first stent company to receive FDA regulatory approval for the start of U.S. IDE clinical studies and
Bifurcation Stent
CE-Mark approval;
 Routinely interface with the Company’s scientific advisors, Board of Directors
 and its investors, and organized large symposium at TCT and PCR;
 Prepared business plan and participated in company road shows to present
AST to many potential strategic partners.
Oratec Interventions, Inc., Menlo Park, CA VP, R&D (3/1999 – 1/2001)
ORATEC was a leading technology innovator in the development and marketing of radio frequency (RF) devices that use controlled thermal energy to treat joint and spine disorders. Oratec was acquired by Smith &
Nephew in 2002.
IDET Spinecath
 Responsible for a team of 24 highly motivated engineers and technicians to develop new temperature and ablation probes, a new 200 watts Arthroscopy generator with unique multifunctional features, and two new IDET spine catheters;
 During this period, Oratec sales grew more than 200% due to the new product launches in both Arthroscopy and spine sectors;
 Worked extremely well with regulatory affairs, marketing, manufacturing, and with outside resources and partners.
SEPEHR FARIABI
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Progressive Angioplasty Systems (PAS), Menlo Park, CA DIRECTOR, R&D (5/1996 – 3/1999)
Progressive Angioplasty Systems was a venture-funded start-up medical device company developing Nitinol stent for coronary artery treatment. PAS was acquired by USSC / Tyco International in 1999.
 Led engineering team to come up with a number of new stent designs and improved stent processes. This work led to a new low profile, highly flexible and optimal radiopacity nickel-titanium shape memory effect Paragon  Stent Delivery
System (SDS);
 Worked closely with marketing, clinical, and number of cardiologists to launch new “Paragon SDS” in Europe and US;
 Coordinated business relationships with potential corporate collaborated, clinical
Paragon Martensitic
Stent  investigators and material suppliers;
Received a “Visiting Scientist” position at Cedars Sinai Medical Center to support clinicians in animal and human clinical testing of angioplasty medical devices.
Guidant Corp, Santa Clara, CA PROJECT LEADER, ADVANCED MATERIALS (6/1989 – 5/1996)
Guidant was a worldwide developer, manufacturer and marketer of medical devices that advance the practice of less-invasive medicine across a wide range of specialties.
Co-Cr Vision Stent
 Led a group of engineers and technicians to develop and manufacture for the first time in the world a commercially hollow non-kinkable nickel-titanium shape memory alloy(Nitinol) guiding member;
 Selected materials and developed processes for several best-in-class guide wires (Balance and BMW), and stents (Multilink and Vision);
 Sole inventor of the first cobalt-chromium stent which led to the launch of one of the most successful coronary stent “Vision” at Guidant.
 Technical advisor for several graduate students and co-founder of
“Biomedical Device Curriculum” at San Jose State University.
OTHERS:
Johnson Controls, Milwaukee, WI
GE Medical Systems Group, Milwaukee, WI
SENIOR MATERIALS SCIENTIST (1986 – 1989)
MATERIALS AND PROCESS ENGINEER (1982-1986)
EDUCATION
PhD, MECHANICAL AND MATERIALS ENGINEERING, University of Houston, Houston, Texas
MS, MATERIALS SCIENCE, University of Manchester, Manchester, England
MSM, MASTER OF SCIENCE IN MANAGEMENT, Stritch College, Milwaukee, WI
BS, METALLURGICAL ENGINEERING, University of Sharif, Tehran, Iran
SEPEHR FARIABI
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SEPEHR FARIABI
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