Medical Device Engineer

Sudhi Gautam

Email: *********@********.***

Address: *** ****** ***** **** *

City: Mountain View

State: CA

Zip: 94043

Country: USA

Phone: 650-***-****

Skill Level: Senior

Salary Range: $200,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Dr. Sudarshan (Sudhi) Gautam

117 Kittoe Drive Unit B, Mountain View, California 94043

aE 650-***-**** aAa ************@*****.***

Objective: C-Level Executive position

Summary

Uniquely qualified Surgeon-turned-Biomedical engineering Ph.D. with over 20 years of broad experience in Medical Devices, Healthcare, Life Sciences and Clinical/Surgical Practice. Currently heads the Medical Devices & Healthcare Solutions part of the Product Engineering Services at a Billion Plus+$, publically traded ISO 13485 certified company with over 40,000 employees.

Visionary thought leader in Medical Devices, a keynote public speaker on Medical technologies with over 20 publications in scientific and industrial journals. Strong blended experience having worked both in the industry and academics across the United States and in India, he is actively networked globally.

Exceptional motivational and leadership skills leading to timely execution and delivery of projects and profits. Deep domain expertise in Medical Devices, Pharma and Healthcare. Function as a Clinician-Surgeon and Engineer, an enviable niche located at the very core of the Medical Device and Life Sciences industries. Adept at conceptualizing cost-effective new medical products/solutions and executing them to highly impactful and timely delivery to meet challenging market timelines for the clients. Globally networked across US, EU and Asia.

aaa Co-owned responsibility for the P&L of $45M revenues of Medical Device vertical. This was accomplished after doubling of revenues of the Medical & Healthcare vertical.

aaa Held P & L as Healthcare Director and instrumental in turning around a Medical education company by doubling revenues in less than a year after taking over as Medical Head.

aaa As CEO of Medtechbridge and as EIR at technology incubators such as Girvan in Silicon Valley, helped startups to conceptualize new medical products, develop high impact clinical, market and business strategies.

aaa Highly commended for successful accomplishment of Clinical validations and Pre-clinical trial evaluations/submissions of cutting edge Medical products and applications. Thorough knowledge of Drug Development process, IND, NDA, ANDA, Adverse Events handling and design of Clinical Research.

aaa Expertise in Clinical Trials, ICH-GCP, 510 K, PMA, Design Control, QSR, FDA and EU Regulations.

Areas of Domain & Technical Expertise

Cardiology, Nephrology, Neurology

Remote Patient Monitoring/Telemedicine

Wireless enablement of Medical Devices

Medical Imaging & Surgical Planning Systems

Life Science Products-Concept to Commercialization

Medical Software & Automation

Clinical Trials, Quality & Process Improvement

Strategic Marketing, Sales/Pre-Sales Team Building

Education

University of Michigan, Ann Arbor, MI Post-Doc Research Biomed Eng, 1998

IIT, Mumbai M. Tech & Ph.D. Doctorate in Biomed Engineering, 1995

Karnatak University, Dharwad MB BS, DLO - in Ear, Nose & Throat Surgery, 1986

Professional Experience

A $1Billion Plus Global company aaa (Confidential)aaa Santa clara, ca

Vice President Head - Medical Device Vertical 2011aaaPresent

aa Provide leadership to the Medical vertical formation, instituting its vision, mission, go-to-market strategy.

aa Primary architect of early wins and efficient closing of deals - building a solid record of credibility.

aa Create and strengthen standing and reputation of the company within the medical devices industry by conceptualizing aaEproof of conceptaaa medical device solutions to Medical Device clients.

aa Obtained the ISO 13485 Certification, which supported the companyaaas entry into the service market.

Patni Americas Inc. aaa Milpitas, CA 95035

Associate Vice President - Medical Devices and Healthcare vertical 2009aaa2011

aa Established the companyaaas ranking as the leader in the medical device and healthcare services space.

aa Initiated the creation of the Medical mechanical engineering side of the Medical BU accountable for producing cost-effective and quality systems that enabled achievement of challenging timelines.

aa Established a solid and loyal client base within the medical device industry by effectively highlighting the companyaaas clinical, surgical, and domain expertise through a range of innovative medical solutions created; thereby achieving leadership position in the local market as well as in the global scale.

Wipro Technologies aaa mountain view, ca

Medical Director - Product Strategy and Architecture 2008aaa2009

aa Integrated product engineering and technology expertise with medical/surgical domain capabilities which led to capturing of numerous downstream projects on behalf of Medical PES.

aa Oversaw the development of market strategies, medical device solutions, and medical device consulting practice procedures.

Medtech Bridge aaa Santa clara, ca

Chief Executive Officer (CEO) 2004aaa2008

aa Rendered effectual support to startup companies in developing technology plans, establishing positioning in the medical devices market, and devising clinical and regulatory strategies.

Sanmina-SCI aaa San Jose, CA

Medical Projects Manager 2003aaa2004

aa Efficiently performed client interfacing role, conducting technology assessments and coordinating research and development activities focused on creating medical devices solutions.

US Education Inc. aaa East Bay, CA

Head of Medical Division 2002aaa2003

aa Boosted revenue within 9 months; managed 15 direct reports; developed medical education programs; identified and recruited teaching faculty; as well as handled budgeting and P & L.

XUMA Inc. and Oceania, - San Francisco, CA 1998aaa2002

Medical Expert Clinical Analyst and Engineer

aa Functioned as liaison to clients with regard to overall transactions involving XUMA, a fast-paced Internet startup catering e-business solutions development, maintenance, and hosting services.

aa Administrated and maintained the HEDIS Reporting, which contained the computerized patient records of Oceania, a company that creates electronic medical records (EMRs), such as WAVE and OC Notes for HMOs and Kaiser.

Earlier Career

University of Michigan, Ann Arbor, MI, USA

Postdoctoral Researcher in Biomedical Engineering

Council of Scientific and Industrial Research, IIT, Bombay India

Senior Research Fellow and Ph.D candidate in Biomedical Engineering

Hospitals in Karnataka, Maharashtra and Gujarat, India

Ear, Nose and Throat Surgeon Clinician- Surgeon

Affiliation

Former Chairman of Life Science Committee, Silicon Valley Association of Startup Entrepreneurs (SVASE)

Ex-Board of Directors at BioDevice Group, Silicon Valley, CA

Awards

aaa Selected for the inaugural class of Emerging Entrepreneurs in Biomedical Technology 2005 at Stanford Universityaaas Bio Design Program

aaa Received the National Research Service Award in Nephrology from the National Institutes of Health in 1997

aaa Awarded with the International Travel Grants and Research Associateship by the CSIR in New Delhi in 1995

Publications

Gautam S.K. (2010). Can coronary CT angiography be a good screening tool to help prevent heart attacks

Medical Device and Diagnostic Industry, a leading Industry Magazine.

Gautam S.K. and Humes D. (2001). Renal Replacement Therapyaa in aaAHandbook of Cell Encapsulation Technology and Therapeutics. Willem Kuhtreiber [Ed] pages 287-299.

Gautam, S.K. and Pandya, V. (1998). Cross flow microfiltration of blood by an extracorporeal Device-a study in parameterization. Transfusion Science, Vol. 18:2.

Gautam, S.K. (1996). Studies in the Development of Membrane-Based Extracorporeal Devices for the therapeutic management of Diseases with Circulating Pathomolecules. in aaABiofunctional Membranesaa Allan Butterfield [Ed.] pages 237-258, Plenum Press.

Gautam, S.K., Jindal, S., Kudva, C and Basu, S. (1995). Exploiting Temperature Dependence to improve Selectivity in Membrane-Based Plasmapheresis, Transfusion Science, Vol 16: 2, Elsevier Science, Exeter.

Gautam, S.K., Kamat, M.V., and Basu, S (1995). Is There a Case for Hemorheological Screening in the Hemocompatibility Testing of Biomaterials

. Biomedical Materials and Engineering, Vol. 5:3, pages 141-149, Pergamon Press.

Seminars and Presentations

Rendered proactive participation to the following public talks, guest lectures and university courses:

aaa Nanotechnology Council (2011)

aaa aaEIs Technology the Answer for Today's Incurable Diseases

aaa - IEEE Consultants (2011)

aaa 7th International Conference on Geriatric Care - New Delhi (2010)

aaa aaERemote Health Monitoring Platform for Elderly in Indiaaaa and aaEUsability Engineeringaaa

aaa aaEMedical Device Design and Developmentaaa - University of California (2010)

aaa aaEHuman Physiology in Health and Illnessaaa - University of California (2010)

aaa aaEState of the Biomedical Industryaaa - American Society of Quality, Alameda, CA (2008)

aaa aaECardiovascular Devices, Biomechanics and Design Challengesaaa - American Society of Mechanical Engineers (2008)

aaa aaEQSRs or Good Business Practices; Medical Device Industry Trendsaaa - BioDevice Group (2008)

aaa aaECardiovascular Physiology and Engineering: Drugs, Bugs and Devicesaaa - UC, Irvine (2008)

aaa aaEBionic BodiesaaaSemiconductor Opportunities in Biomedical Industryaaa - MIT Alumni Association (2007)

aaa aaEWhat is happening in the Biomedical Industry

aaa - North American Taiwanese Association (2007)

aaa aaEMedical Education: Is it necessary for Life Science Projects

aaa - PharmaLIG, N. California (2007)

aaa aaEBioDevice Therapies: A look back to the futureaaa - BioDevice group, Silicon Valley, CA (2006)

aaa aaEOverview of Medical Device Industryaaa - University of California, Berkeley (2006)

aaa aaaMedical Devices aaa The Basics and the Businessaaa - University of California, Berkeley (2006)

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