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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Combustible Gas Detection, Gas Industry, Industrial Safety, Industrial Automation
Expert is a Professional Product Manager and highly skilled in developing and marketing products from conception through entire product life cycle. Exceptional track record of improving products and leading teams, specializing in creating value for manufacturers of B2B industrial products,…
Heterogeneous Catalytic Hydrogenation for the Production of Fine Chemicals
Expert has applied his organic chemistry/heterogeneous catalysis/reaction engineering background to the development of processes for the production of pharmaceuticals, vitamins and nutraceuticals, agrochemicals, flavors and fragrances, liquid crystals and fine chemicals as well as base chemicals. He has broad experience…
Process & Control Engineering, Operational Excellence, Reliability & Expert Witness
Multi-talented and versatile leadership & management skills with geographically and culturally diverse teams & projects. Broad and diverse experience in the refining, petrochemical, chemical, and biofuels industries. Project management skills include project definition, budget, scope & proposal development, and cost…
Petrochemical, Pulp & Paper, Distillation, Industrial Accident Investigation, Overpressure Investigation and OSHA Compliance
Expert has over 40 years' of engineering design in the Chemical Process and Pulp and Paper fields. He has held positions of Production Engineer, Technical Director, Quality Control Engineer, Process Engineering Department Head, Senior Engineer. His experience includes many years…
Instrumentation and Control System Engineering, FEED, Data Sheets, DSC, ESD, F&G, Tank Gauging
Design, Construction of Instrumentation, Control & Safety systems for Oil production facilities & Refinery. Development of C&E diagrams, input to P&IDs, control loop design, Instrument Index, DCS/ESD I/O list, instrument installation drawings, Loop, wiring/termination drawings, cable schedule. Produce narrative descriptions…
Flare Design, Combustion & Environmental Studies (Radiation & Plume/Toxic Calcs)
Over eighteen years of experience in design, project engineering and business development of oil and gas-related projects. Work experience includes writing specification, sizing and selection of flare systems, instrumentation, preparation and evaluation of equipment bid packages, MFD development, design of…
Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA devices…
Polymer Design and Synthesis, Coating Formulation, Defect Analysis, Process Improvement
Expert in Formulating, Applying, Curing, and Troubleshooting Coatings for Ophthalmic Lenses, as well as Other Transparent or Polymeric Articles Chemistry With over 25 years of industrial experience, Expert, a degreed chemist, is an authority on the materials, equipment, and processing…
Risk Management, QRA, and consequence Modelling
The area of expertise is in Hazard Management,Consequence Modelling, and Quantitative Risk Assessment. Expert has extensive experience in process safety including HAZID, HAZOP, Bow-tie, Safety Critical Element, fire and explosion consequence modelling, QRA, dropped object modelling, emergency escape and rescue…