Intellectual Property and Regulatory Consultant Specializing in Patents on and FDA Regulation of Novel Medical Device and Biotech DevicesIntellectual property (IP) and regulatory strategy.FDA regulation of novel products such as wearable medical devices, and electronic cigarettes.Patent protection of drugs, medical devices, dietary supplements, and tobacco products.Patent landscaping and freedom-to-operate analyses.Consultation with and representation before U.S. Food and Drug Administration (FDA).IP and regulation surrounding novel technologies such as RNAi, gene editing, and synthetic biology.In vitro diagnostic medical device and consu...

Water and Wastewater Treatment Consultant with Expertise in Design, Installation, Commissioning, Operations of Maintenance of ETP (Effluent Treatment Plants) and Sewage Treatment Plant.Standard process operations of maintenance of ETP (Effluent Treatment Plants) and sewage treatment plant.Waste water treatment process (SBR, MBR, MBBR, trickling filters and conventional activated sludge process, filtration).Installation and commissioning of wastewater projects (STP, WTP and ETP).Design of water and wastewater treatment facilities.Evaluation and up gradation of water and wastewater treatment plants.Technology-commercial proposal, technical r...

Manufacturing Operations Process Development-Aerospace, Automotive, and Medical Device Industries ExpertManufacturing process development: streamlining, characterization, optimization and validation (IQ,OQ,PQ,TMV,DOE) practices.Strategic vendor and contract manufacturing (CM) partnership and streamlining of implantable device manufacturing technology and transfer process.Interacted and represented department during regulatory audits, including FDA, and TUV.Diversified experience in Medical Device, Aerospace, automotive and consumer products industries.Equipment life cycle process including PM program, database improvement, define means to...

Ph.D. Material Engineer with Expertise in Spun Molybdenum Crucibles, Sapphire Crystal Growth, and Tungsten Heavy Alloys for Penetrators, Radiation Shielding and Counter Weights for Medical Device and MilitaryAdvanced materials technologies.Produce radiation shielding and counter weights through the science in spun molybdenum crucibles for sapphire crystal growth and tungsten heavy alloys penetrators.Identify products to maximize potential marketing value in the plate, sheet, foil, rod, wire, and fabricated components for customers in multiple industries.Large-scale production of sapphire for watch faces and optical windows.Government cont...

Product Commercialization Marketing Consultant in Biopharmaceutical, Medical Device and Medical Diagnostics Industries, Litigation - Support and Testifying ExpertBiopharmaceutical product commercialization, diagnostic and medical device markets with over 30 years of success.Over 20 years operational leadership in mid-size to large biopharmaceutical companies and established medical device firms.Marketing, market research, pricing and reimbursement, business planning, and sales, contributing to ten new product launches in the life science industry with consulting engagements and industry experience spanning thirteen therapeutic classes.Ad...

Medical Device Marketing, Sales, Distribution, Business Development, Product Development Consultant: POCT, diagnostics, pediatrics, endoscopy, critical care, cardiovascular surgery, ENT/respiratory-care, IVD, MIS, IVUS, interventional-cardiology devices, and imaging.Point-Of-Care (POCT) diagnostics, pediatrics, endoscopy, critical care, cardiovascular surgery, ENT/respiratory-care, IVD, MIS, IVUS, interventional-cardiology devices, and imaging."Stage and gate process," product pricing strategies, branding, strategic partnerships and maximizing sales for profit and market share in new and mature markets.Business and engineering background o...

Railroad Industry Consulting Specific to: Government and Employer set Compliance, Safety, and training Operations. International and Military Railroad OperationsSummary Railroad industry veteran with executive level and professional experience. Global operations experience in railway freight logistics, compliance, and training standards. Implement high performance work culture that consistently achieves B2B success in a $30 Billion industry.  Leader in railroad safety and training operations with strong focus on government and employer set compliance, International, and military railroad operations.     &nbs...

IT Business Consulting Providing Project Management and Functional Consultant Expertise: Cloud-Based Software Solutions Understanding Manufacturing, Implemented Production Planning Solutions-Capacity Summary Accomplished, innovative, hands-on, executive-level consultant with excellent leadership ability and over thirty-five-year track record of consistent value add and continuous improvement activities in the areas of Information Technology domestically and globally. A strong suite of skills that includes hands-on experience in delivering business-driven, strategic technology solutions, enterprise architectures, business integration, o...

Ph.D. Legal Consultant, Providing Various Expert Support in: FDA Approvals, Evaluations-Patents Medical Devices and Drugs, Data Integrity and Software Development, Author and Expert Report Writings.  Regulatory, Food and Drug Administration (FDA)-related provisions and cases providing support to legal clients in areas: Death or injury caused by drugs, biologics or medical devices, (patents, insurance claims, wrongful termination, trade secrets, merger and acquisitions. Develop and present more than 40 FDA related technical, regulatory and compliance topics to over 50,000 participants. Depositions. Develop case-specific informat...

Risk Management Consulting in Business Continuity Planning, Management, Testing for Small and Mid-sized Businesses Throughout the United States and Internationally. Business continuity Disaster recovery Financial technology controls Financial technology problem management Risk management Technology control Compliance: Federal Deposit Insurance Corporation (FDIC) and European  Pharmaceutical Research Association (PRA)  Standards. Cyber security Digital product management Financial customer service Project management Agile methodologies Microsoft and Google applications Rally