Raya Fryer Email & Phone Number

Irvine, California, United States

• Perform experiments to evaluate the development and assessment of new technologies for potential products following the regulatory guidelines / standards (FDA, TGA, ISO etc.) • Perform technical studies for 510(k) submission for endoscope sterilization in STERRAD systems.• Contribute to the origination or direction of experiments, through the development of methodologies, review, analyze, interpret data and prepare reports.procedures per quality management system… Show more • Perform experiments to evaluate the development and assessment of new technologies for potential products following the regulatory guidelines / standards (FDA, TGA, ISO etc.) • Perform technical studies for 510(k) submission for endoscope sterilization in STERRAD systems.• Contribute to the origination or direction of experiments, through the development of methodologies, review, analyze, interpret data and prepare reports.procedures per quality management system regulations.• Manage independent projects under the guidance of process leaders and project facilitators• Prepare protocols and design experiments to execute research studies under supervision tosupport product development from feasibility to final product verification / validation• Write and review technical reports and standard operating procedures per quality management system regulations• Support to develop solutions to problems of limited scope and complexity through the exerciseof judgment within defined practices and policies to determine appropriate action• Effectively communicate experiment status / testing results to others• Perform duties in accordance with policies and procedures and in to comply civil rightsrequirements• Support laboratory equipment validation program• Support OOS, NC, and CAPA investigations to higher level scientists as needed.• Provide training to other laboratory personnel in execution of testing procedures.• Responsible for communicating business related issues or opportunities to next management level.• Provide support to other programs and project teams that require test.• Work with cross functional teams to reach consensus.• Support team focused on identifying and implementing process level efficiencies.• Support in maintaining awareness of the advances and needs in sterilization / disinfection, microbiology, and biocompatibility.• Contribute to building extra ordinary team environment Show less

Irvine, California, United States

Performed science and industrial studies.Performed material compatibility studies in STERRAD sterilization systems.Collected, documented, summarized and organized data in projects.Wrote technical reports after finishing studies and protocols.Assisted in new product development projects.Worked with teams in problem solving and designing techniques to enhance test performance in multiple laboratories.maintained laboratories during and after testing.Audited laboratory… Show more Performed science and industrial studies.Performed material compatibility studies in STERRAD sterilization systems.Collected, documented, summarized and organized data in projects.Wrote technical reports after finishing studies and protocols.Assisted in new product development projects.Worked with teams in problem solving and designing techniques to enhance test performance in multiple laboratories.maintained laboratories during and after testing.Audited laboratory notebook periodically. Show less

Irvine, California

Assisted in Characterization Studies of Cleaning Process Indicator (CPI) Prototype ReadersAssisted in CPI in an NPD; ASTM soil PreparationQuality Control of ASTM Soil using Cleaning Kinetics Using UV/Vis and Cleaning Response using Thorlabs OSA (Optical Brassboard)Assisted in the development of patent pending technique to rapidly sterilize large endoscopes.Performed inoculations of biological indicators.Performed testing in all STERRAD® systems for a new STERRAD®… Show more Assisted in Characterization Studies of Cleaning Process Indicator (CPI) Prototype ReadersAssisted in CPI in an NPD; ASTM soil PreparationQuality Control of ASTM Soil using Cleaning Kinetics Using UV/Vis and Cleaning Response using Thorlabs OSA (Optical Brassboard)Assisted in the development of patent pending technique to rapidly sterilize large endoscopes.Performed inoculations of biological indicators.Performed testing in all STERRAD® systems for a new STERRAD® cycle.Review and maintained laboratory notebooks.Assisted in use of CFD software (MacroFlow) to model the sterilization process.Developed color analysis procedures to assess the color of chemical indicators. Show less

Irvine, California

Performed testing using the STERRAD® system (100NX, NX and 100S) to develop VELOCITY Biological Indicator (BI) and the BI readerSummarized fluorescence test data collected from the VELOCITY BI reader for 510(k) protocols.Trained new technicians on the use of the prototype reader and proper documentation methods.Developed reader calibration methods and test methods for transfer to QA.Assisted in drafting protocols and reports for the VELOCITY project.Performed enzyme assays… Show more Performed testing using the STERRAD® system (100NX, NX and 100S) to develop VELOCITY Biological Indicator (BI) and the BI readerSummarized fluorescence test data collected from the VELOCITY BI reader for 510(k) protocols.Trained new technicians on the use of the prototype reader and proper documentation methods.Developed reader calibration methods and test methods for transfer to QA.Assisted in drafting protocols and reports for the VELOCITY project.Performed enzyme assays in microplate reader.Trained other technicians on test procedures, GDP, standard operating procedures, and work instructions. Reviewed and maintained laboratory notebooks.Troubleshoot instrument, STERRAD® errors and perform system revalidations. Show less

Riverside, Ca

• Coordinated with Director/PI to develop/maintain the current criteria for study sponsors to be conducted at the Institute• Worked with community PI and Sub-I relationships and complete study; screen and recruit patients who might qualify for study trials. Plan and coordinate the initiation of each research study protocol• Prepared, collected and submitted regulatory study documents.• Ensured regulatory compliance and reporting, submitting AE, SAE, IND safety reports. • Updated… Show more • Coordinated with Director/PI to develop/maintain the current criteria for study sponsors to be conducted at the Institute• Worked with community PI and Sub-I relationships and complete study; screen and recruit patients who might qualify for study trials. Plan and coordinate the initiation of each research study protocol• Prepared, collected and submitted regulatory study documents.• Ensured regulatory compliance and reporting, submitting AE, SAE, IND safety reports. • Updated and created new site's standard operating procedures (SOPs).• Performed set up, implementation, and completion of studies, collecting all pertinent patient data. • Updated regulatory documents as required, working on multiple protocols. • Maintained patient recruitment and pharmacy logs, assisting with archival and storage of study documents. • IRB Submissions and Reporting. Show less

Signal Processing in MATLAB and AcqKnowledge. Doing different experiments on the participants using Biopac.

Researching about the Abdominal Aorta Aneurysm using CFD method.

Tehran Province, Iran

• Identified opportunities for business growth • Independently problem solved and created solutions• Possession of astute commercial business acumen• Well-honed analytical skills and budget management• Traveled regionally for 2-3 nights approximately every twelve weeks.

Tehran Province, Iran

Been trained and completed courses at Medical Equipment Department