Domestic and International experience in the plastics Industry, working in product design, and development, manufacture of automotive, medical, toy and consumer products.Over thirty years of domestic and international experience in the plastics industry.Plastic product design, development and manufacture of medical devices, automotive parts, toys and consumer plastic products.Expert of plastics end use markets, and plastic (polymer) type commonly used for each application, with special knowledge in the medical device field.Plastic material selection criteria and plastic product design review.Shop floor knowledge of plastics processing, too...

Consultant for Design and Testing of RF, Microwave, Sensor and Medical Device Electronic SystemsAll analog hardware designs.All switchmode and linear power design topologies.433MHz to 5.4GHz ISM/Bluetooth RF link designs.Passive and active RF and microwave design (up to 30 Ghz).Nonlinear and linear control loop analysis, synthesis and design for high power/voltage applications.Passive and active impedance matching/filtering network design.PCB design of switchmode power, RF/microwave, analog and high speed digital.Multi-system physical simulation and modeling.Multi-disciplinarian project management.Invasive and noninvasive medical equipmen...

High Power Electron Beams Technology and Business ConsultantTechnical and business expertise for industrial electron accelerator projects.Led the team that developed Atomic Energy of Canada's high energy, high power electron beam technology.Managed research and development programs to develop new uses for electron beams, including food irradiation, plastics, composites and cellulose treatment.Evaluate products for feasibility of electron beam sterilization - including materials compatibility, dose distribution and process efficiency.Determine electronic beam equipment requirements - power, energy and other.Estimate dose distributions and p...

Consultant for the Use of Electron Beam for all Types of Product SterilizationEvaluate products for feasibility of electron beam sterilization, including materials compatibility, dose distribution and process efficiency.Determine electron beam equipment requirements - power, energy and other.Estimate dose distributions and perform detailed studies of max/min ratios.Provide capital and operating cost estimates and prepare or review capital investment schedules and business plans.Prepare and evaluate equipment tender documents with potential suppliers.Provide facility design concepts supported by Monte Carlo based shielding analyses.Prepare...

Mechanical Engineer Medical Device Consultant for Endoscopic, Surgery, Devices, Respiratory Sleep Apnea DevicesMedical DevicesMedical device product and process development.Design and development of respiratory devices.Medical device injury analysis.Medical device product failure analysis.Diagnostic, monitoring, sedative and therapeutic drug delivery devices.Laparoscopic and endoscopic surgical devices.Surgical stapling devices and skin stapling devices.Oxygen concentrators.Oxygen conserving devices.Sleep Apnea therapy devices, (CPAP, BPAP devices).Spirometry, spirometers and flow sensors.Compressed medical gas storage and delivery.Design...

Healthcare Technology Consultant Specializing in Medical Devices Used in Hospitals37 years of national expertise managing the selection, maintenance and safe and effective use of medical equipment and systems used in hospitals.Medical device failure discovery evaluation in various circumstances; determine patient misuse, clinician errors, and root and secondary causes.Mitigating risks through independent test labs and working with healthcare providers and manufacturers.Through clinical and hospital administrative experience, able to convey a broad technical perspective allowing discussions for patient safety improvements and reducing risks...

Failure Analysis Expert for Medical Devices, Specializing in Surgical Fires, Oxygen Safety, Surgical LasersOver 30 years investigating expertise of failures, malfunctions, and misuses of devices, systems, methods, and procedures in various industries.Evaluating and investigating healthcare technology. providing over 20 years' experience.Surgical fires, oxygen safety, surgical lasers, failure analysis, root cause analyses (RCA), and failure modes and effect analysis (FMEA).Quickly and accurately determine problem causation for hospitals, law firms, insurance companies, regulatory agencies, and manufacturers.Educator - Instructor, Physics.Ex...

Medical Device Consultant (In-Vitro Diagnostics - ISO 13485, 510k, De Novo, CE, CFR 820) with International Experience in Consulting, Program/Project Management, and Manufacturing510k submissions in medical devices.New business and PMP skills managing multiple international projects.Technical proficiencies and strategic planning to optimize existing products and develop new IVD assays.Risk management: Providing risk management assessments, FMEA - design and process, and developing risk management protocols.Composing and documenting product requirements specific to FDA, CLSI, ISO and CE regulations.Technology transfer.Regulatory activities...

Medical Device Expert Specializing in Ear, Nose and Throat Surgical Devices and Cardiac DevicesEar, Nose and Throat (ENT) surgical devices.Neurological devices, electrical stimulation and neurophysiological monitoring.Cardiac devices and cardiac monitoring.Extracorporeal, renal and blood processing devices.Tissue Engineering and artificial organs.Expert Witness ExperienceCause of death of patient on a medical device (tracheostomy tube). Provided analyses, reports and deposition for this case.Independent Consultant, 2012 - PresentAnalysis and char...

Expert on Human Device Interface Evaluations for Easy, Safety and Ascetics of UseDesign support to optimize the human interface of products, particularly medical devices.Product design development to improve human issues of products: Ease of use, ergonometric, safety and human appeal.Human factors analysis of product design and product use.Human factors consulting and product usability testing to optimize product ease of use.Prototyping products to evaluate for ease and safety of use.Side by side human factors analysis of prototypes and products opposite alternative competitive products.Ethnographic product and marketing research to under...