
Ajit Mishra
• 30 years experience in medical device, diagnostics, biotechnology & drug/device combination product R&D, Engineering, Program Management, M&A,... | San Francisco, California, United States
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Ajit Mishra’s Emails am****@be****.com
Ajit Mishra’s Phone Numbers No phone number available.
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Ajit Mishra’s Location San Francisco, California, United States
Ajit Mishra’s Expertise • 30 years experience in medical device, diagnostics, biotechnology & drug/device combination product R&D, Engineering, Program Management, M&A, Quality, Regulatory, Manufacturing, & Clinical Research, 13 years in executive leadership positions with increasing levels of responsibility • Demonstrated track record of developing game-changing medical devices that have generated several billion dollars • Managed programs to develop / test medical devices with annual revenues of up to 1 Billion • Led teams of up to 100 members in US, UK, Netherlands, Denmark, China, Japan, Taiwan, Philippines, Puerto Rico and India • Expertise in development of orthopedic (knees, hips, trauma, robotics) & spinal implants & instruments, cardiovascular devices (stents, catheters, trans radial sheaths, PTCA & PTA balloon catheters, guidewires, heart valves), software-driven in-vitro diagnostic devices (Molecular Diagnostics, Immunoassay, Lateral Flow, coagulation monitoring, platelet function, blood glucose monitoring), digital health systems, drug delivery devices, blood transfusion devices, wound management devices, dental implants, biomaterials • Extensive experience in working with FDA to facilitate approval of new products (Class II and III) • Led a company through FDA inspection, with no 483’s and no Observations • Led a company through Notified Body audit; achieved ISO 13485 certification and CE marking • Expert in FDA's Design Controls & Quality System Regulations • Extensive experience in collaborating with clinicians to identify and validate product concepts • Expertise in Strategic Portfolio Management and Stage Gate Process • Experience in start-ups to 50 Billion medical device companies • Experience in interactions with stock analysts, Venture Capital, Private Equity, & Board of Directors • Demonstrated track record of building high performing teams • Inventor of 18 patents with 5 pending, author of 57 publications & conference presentations
Ajit Mishra’s Current Industry Medical Device And Diagnostic Consulting
Ajit
Mishra’s Prior Industry
Smith And Nephew
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Kinetic Concepts
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Johnson And Johnson
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Terumo Medical
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Telcare
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Stryker
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Accriva Diagnostics
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Spineovations
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Zoetis
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Beckman Coulter Diagnostics
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Medical Device And Diagnostic Consulting
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Work Experience

Medical Device And Diagnostic Consulting
President and CTO
Sun Oct 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Beckman Coulter Diagnostics
Head of Research And Development, Microbiology
Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Zoetis
Vice President, Global Diagnostics R&D
Tue Jan 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Spineovations
Vice President, Research & Development
Sun Oct 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Accriva Diagnostics
Vice President, Research & Development
Thu Jan 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Stryker
Vice President, Research & Development
Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Telcare
Vice President, Operations
Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Terumo Medical
Director, New Product Development
Thu Jan 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Johnson And Johnson
Director, New Product Development
Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Kinetic Concepts
Senior Project Manager
Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jun 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Smith And Nephew
Senior Project Manager
Sun Jan 01 1989 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)