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...

Senior Environmental Consultant with Chemical and Aerospace Manufacturing Experience Specializing in Air Permitting, Hazardous Waste Management, Environmental Gap Analysis, Environmental Management Systems and Environmental Site AssessmentRCRA (Resource Conservation and Recovery Act) compliance, including hazardous materials management system development and pollution prevention program development.Compliance with EPA regulations.Developing ISO-14001 management systems including third party ISO-14001 audits.Air permitting requirements and acquiring air operating permits.Wastewater permitting requirements and compliance.SPCC,(Spill Preventi...

Ph.D. Chemical and Biochemical Engineer Specializing in Cell Culture and Sterile Drug Product Process Development, Technology Transfer, Scale-up, and Manufacture.Fermentation and cell culture development, scale-up, and manufacture.Sterile drug product development, technology transfer, and manufacture.Current good manufacturing practices (cGMP).Metabolic modeling.Educator for undergraduate Bioengineering program and workshop facilitation.Undisclosed Company, Owner, 2011 - PresentPr...

Biomedical Engineering Expert Specializing in Bone Implants, Dental Biomaterials, and Stem Cell SeparationsSetting up research labs for residency programs.Bone implant design and testing.Dental biomaterials development and testing.Stem cell separations and testing.Bone cement based drug delivery.Undisclosed Medical Center, Director, Orthopedic Bioengineering, Lab., 2007 - PresentWork with surgeons and residents (different specialties) to develop research projects.IRB and IACUC application process.Develop bioskills cadaver laboratory s...

Biotechnology Expert with Extensive Domestic and International Product and Process Development Experience in Pharmaceutical, Biofuel, Chemical, Agricultural and Nutraceutical IndustriesConducting and directing product, process and manufacturing development activities for biologically-derived materials used in the pharmaceutical, biofuel, chemical, agricultural and nutraceutical industries.Production of biosimilars, monoclonal antibodies and industrial recombinant proteins. Activities include research, development, production, biocomparability, technology management in CMOs, FTO landscape critical for biosimilars, licensing, business deve...

Vinyl Acetate Construction Adhesive Formulation and Use ExpertResearch and development in polymers and formulations for adhesives and coatings.Vinyl acetate emulsions and polyvinyl alcohol used in dry wall joint compounds, cement additives and mastics.Vinyl acetate ethylene emulsion polymers for construction and adhesive applications: Cementitious applications (including tile mortars, patch, and EIFS, Exterior Insulation and Finishing Systems), joint compounds for finishing gypsum board, caulks and sealants, and adhesives for packaging, laminating and pressure sensitive applications.Redispersible powders made from vinyl acetate copolymers...

Microwave Systems, Antennas, and Components Expert, Specializing in Shaped Beam Antenna DesignDesign, manufacture and test microwave antennas, components, and systems.Design, manufacture and test servo controlled antenna positioners.Forensic engineering related to microwave devices, industrial accidents.Computer Specialist: WIN and MAC, IT functions, networking, programming.Human Engineering: Intuitive design for simple operation of complex devices.Expert Witness ExperienceLA Federal Court, GSA Court of Appeals, (major Television News Company).Patent Infringement-Fair Trade Law.Industrial Accident: Accidental Electrocution,(Television New...

Robotic Systems Expert with extensive experience in software, hardware, automation and instrumentationSpecialist in computer controlled machine and related software and hardware engineering.Software development for machine and robotic movement.Technical architect of multi-million dollar projects with Fortune 500 companies and Federal agencies including: NASA, Whirlpool, Michelin, Merck, Medtronics, Raytheon, Lockheed Martin, Northrop Grumman, the US Air Force, U.S. Army and U.S. DOE.Extensive experience and training in software, hardware, machine, automation and instrumentation.Author and architect of five copyrighted software systems.Exp...

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...

Analytical Separations Scientist for Pharmaceutical and Biopharmaceutical ApplicationsAnalytical chemistry and biochemistry.Analytical biotechnology and biopharmaceutical regulatory science.Analytical method development and validation.Separations science and mass spectrometry.Thermal stability studies of immunoglobulins.Separation and quantitation of monoclonal antibodies in cell growth.Validation of chromatographic methods.Derivatization approaches for a fermentation derived, cyclic peptide analog.HPLC - High Performance Liquid ChromatographyUPLC - Ultra Performance Liquid ChromatographyGC - Gas Chromatography or General ChromatographerSF...