Solely responsible for long term life-testing of a two-part, combination Medical Device (BLU-U and Levulan Photodynamic Therapy Devices), from inception to completion of the Design History File.Helped develop supplemental testing to expand the data set thereby, allowing the complete testing cycle to be leveraged to support a product enhancement submission, which was summarily approved by the FDA.Directed and assisted in the build of Validation units with responsibility for inspecting those units. Reviewed and validated all test fixturing in addition to editing and verifying all protocols and procedures. Developed test methods and performed characterization testing for Levulan Photodynamic Therapy devices. Recorded and presented data in design reviews to help finalize decision-making processes.Proofread, streamlined and executed Qualification protocols.

Primary contact to hospital and donor sites with responsibilities for procuring, imaging, documenting and then reconstructing CT and MRI spine images into three-dimensional engineering models for implant positioning, anatomical dimension analysis, and bone mineral density analysis. (Monthly Travel 10-15%)Increased the number of donor centers by 75%, while reducing imaging costs by 33% through relationship building.Assisted with clinical monitoring and audit prep for six European sites over three years. Focused on bio-mechanical and bench-top testing including Af, static and cyclic fatigue testing, often using cadaveric spine specimens to test "Barrier" and "Anchor" Implant Systems. Proficient in testing to a variety of ASTM and ISO standards, including ISO 9000(1), (4) & 13485, also Universal Precautions compliant.Testing resulted in approval of company's first product(s) in Europe, and was a significant component of Intrinsic's IDE applications to the FDA in the U.S.Created and maintained test data and reports, including spreadsheets and databases for a wide variety of testing. Also used a series of macros and templates to help manage the data and generate reports quicker and more efficiently. SAFETY OFFICERIn addition, I served as the company's Lead Safety Officer with OSHA training, responsible for, but not limited to; New Employee Training, Bloodborne Pathogens, HazMat Training, Radiation Exposure, Medical Waste and Evacuation Procedures.

Specialized in robotic testing using XRF technologies, in conjunction with six Adept tri-axis robots simultaneously.Extensive electromagnetic and hybrid mapping, working in both distorted and undistorted fields.Developed test parameters, protocols and assisted with the design of experiments for new products. Performed experiments to further develop testing methodologies for working in the ENT-Cranial environments.Trained Production, Inspection and Manufacturing staff in test procedures, time-management and scheduling techniques along with calibration of all equipment.Assisted with QA, QC, Verification and Validation procedures and personnel along with authoring Work-Instructions, SOP's ECO's and technical reports, along with creating custom multi-forms as needed.

Focused on bone morphogenetic proteins with additional experience in oncology and hematology studies. (10 drugs, spanning 77 protocols in phases: Pilot - III)Organized and formatted data for medical review and statistical analysis, ensured validity of clinical trial data, monitored timely data entry, reviewed data/annotations and made appropriate corrections to the database.Participated in audit of protocols, performed organization and archiving of locked studies. Assigned batch ID's; scanned, loaded and indexed images for data entry; entered and verified trial data.

Performed Striped Bass sampling, dissections and identification of prey items including juveniles.Conducted prey collections by trapping and beach seining, while instructing local school children. Processed fish and their prey for energy density models, published at completion of study.Assisted with Circle-Hook and Tagging study on Bluefin Tuna to analyze stress physiology and post-release survivorship. Completed data analysis, transcribed, process and audited field and laboratory data using several software packages.

Monitored clinical trials for valid data and designed data collection instruments, while reviewing automated validation system output to correct/resolve discrepancies according to established SOP. Tracked and managed the flow of data to and from investigative sites, reviewing resolutions provided by the investigative sites and made the appropriate corrections to the database. Maintained the integrity of the study protocol and assisted in preparations for drug company site visit/audits and assisted in the performance of endpoint data tests while using strict adherence to proper SOP and GCP standards.

Primarily: Validation and QA, QC of Biomag product kitsPerform Bioassay, Enzyme ImmunoassaySpectrophotometry, Mass SpectrometryNucleic Acid Synthesis (Expedite)DNA & RNA handlingReceptor Binding TechniquesConduct ELISA, HPLCWork within QC/GMP/GLP compliance standards

Marble Bluff Fish Facility - Operated fish lock and transport system including associated weirs, experimenting with attraction flows to maximize success during record run of spawning Qui-ui, (a freshwater sucker fish) for the Paiute Indian tribe. Lahonton National Fish Hatchery - Conducted raceway maintenance, grading, feeding, fin clipping and fish distribution techniques for the Lahonton Cutthroat Trout.U.S.G.S./Biological Research Division - Performed Ichthyoplankton netting, sampling and identification.Nevada Division of Wildlife - Conducted electro-fishing, creel census and watershed characterization. The Nature Conservancy - Performed stream survey, habitat reconstruction and watershed assessment.