Medical imaging, electronics, semi-conductors, medical devices, sensors, MEMS (Micro-Electro-Mechanical Systems), signal processing, image processing and ultrasound.Industrial and applications including, imaging, consumer electronics, biometric security, and electrical power delivery.Intellectual Property: Patent development, analysis, licensing, and strategy.Expert Witness ExperienceMedical malpractice (spinal injury, working with neurologist) - retained, filed initial statement with Court and deposition work.Product liability - wheelchair.Two patent infringement cases involving wearable consumer electronics.Trade secrets case involving...

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...

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...

Innovative registered mechanical engineer for development and ISO9001 manufacture of medical cutting devices such as surgical quality tissue cutting edgesMedical device development and manufacturing implementation.Medical device and other product and process development including: Disposable and reusable medical device design, prototype and clinical supplies prototype fabrication and testing, manufacturing systems design and development, manufacturing tooling and fixture design, process piping, equipment installation and validation, sterilization and packaging validation.Product and manufacturing process improvement: Design of experiment...

Experienced Senior Scientist Obtains Proven Track Record in Research and Product Development, Support, Validation. Clinical Assay Development, Medical Devices, Planning- Executing 510(k) Applications.Summary Experienced Senior Scientist with a proven track record in research and product development/ support/ validation. Clinical Chemistry Expert; polymer chemistry, assay development, medical devices, fluorescence, planning and executing 510(k) studies, writing and editing 510(k) applications. Subject matter expert for chemistry and test method validation on behalf of clients’ companies. Numerous processes validation during compli...

Nutraceutical, Health Foods, Dietary Supplements and OTC Products Consultant. Custom Formulations for Dietary Supplements and OTC Products; Solid, Semisolid and Liquid Delivery. Sample Development, Research and Development, Raw Materials Sourcing and Specifications.Nutraceutical, Health Food, Pharmaceutical, and Medical Devices, new product development and research and discovery.Nutraceutical formulation development; Identifications and evaluation of new materials; process quality and improvement; quality system; and technical support.Dietary supplements and OTC product formulation.Ingredients sourcing for dietary supplements.Raw materia...

Commissioning and Qualification of Solid Oral Dosage Facilities, Operation Excellence in Supply Chain, Drug Master Files Review, Validation of Analytic Control, Implement EHS Management Systems Quality management system: Design, Standard Operating Procedures (SOP) training, auditing, upgrading quality systems. Design of oral dosage manufacturing processes. Design of manufacturing process and equipment’s User Requirement Specification (URS). Commissioning and qualification of process equipment, clean rooms, HVAC, and purified water system. Market research, business plan, product targeting. Regulatory affairs: Review of parts 1...

Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...

Providing Diagnostics in Blood Collection Platforms, Develop Control Sensors and Instrumentation for the Pulp & Paper, Plastics Industries, Commercializing New Infrared & X-ray Sensor Technology. Accomplished senior research and development leader, Ph.D. in physics, executing extensive experience in new product development, and focus in optical and medical devices and diagnostics. Targeting customer needs, assessing new technologies, and developing innovative business and technology opportunities. With both Fortune 500 and entrepreneurial, and startup company experience, bringing dynamic leadership and technical expertise to instrume...

OTD/Occupational Therapy and Psychiatric Industry Writing and Author, including the Legal SectorRegulatory Medical Writing Clinical Medical Writing Editing Quality Control Business Development Expert Witness Experience Writing Experience (Phases 1, 2, 3, and 4): Wrote and edited ICH-compliant documents, including investigator brochures (IBs); Investigational New Drug (IND) applications. Marketing Authorization Application (MAA); informed consent documents (ICF); protocols and amendments. Clinical trial agreements (CTAs); clinical study reports (CSRs). Clinical evaluation reports (CERs); biologics license applications (BLA);...