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Medical Device Development
BSME - Mechanical Engineer: 40+ years Medical Device design & development (13 patents) - Drug delivery devices, respiratory care devices, hemodialysis, and blood collection devices, in-vitro diagnostic instrument, and cartridge devices; 25+ years medical device product liability and patent infringement…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Biocompatibility Testing and Biomaterials for Medical Devices
Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…
Food and Beverages, FMCG, Dairy and Milk, Agri-Business, Chemicals, Specialty Chemicals, Pharmaceuticals, Health Care and Medical Devices, Industrial Chemical Ingredients
Expert has 34+years of extensive industry experience, is a Highly Qualified, Senior Professional Consultant, and is well known internationally. He has a Graduate Degree in Agricultural Technology-B.Sc. (Agri Tech); an MBA (Masters in Business Administration) and a Ph.D. (Doctor's Degree…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
battery management system, power semiconductor device new product development, electronic component failure analysis
Adtec Electronics, Bangalore, India, 3/2016-3/2017, facilitated turn-around by developing partner for the re-launch of telemedicine solutions in rural India. Linear Labs, Ft Worth, TX, 9/2013-10/2013, design, build, test, and patenting of power electronics controls for a novel homopolar motor. Supreme…
Biomaterials, Biotechnology, Medical Devices, Polymer Chemistry, Biomedical Engineering, Materials Engineering, Healthcare (regulatory), Intellectual Property Strategy
Expert has more than 20 years experience in biomaterials and medical devices, both in industry and as a university professor performing research. His research has a translational focus, so he has conducted numerous pivotal animal studies related to the fields…
Medical Devices, Diagnostics, Digital Health
Expert has 20 years of leadership experience in medical device/life sciences marketing in small start-ups and Fortune 100 companies. Following an industry career Vice President of Marketing for Oridion (acquired by Covidien) Medical, Director of Marketing for Philips Medical, and…
Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt
Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…
Magnetic and Electromagnetic Devices
Expert possesses a strong background in electromagnetics and magnetics. He has accrued significant experience in magnetic materials, permanent magnets, inductors, transformers, magnetic coils, electromechanical devices, electrical machines, and electrical and magnetic measurements. Expert's experience addresses thermal design of cooling systems…