Roman Zorin
******@*****.***
Seeking to apply the diverse technical and professional experience in Medical Device industry. Exceptional analytical skills as demonstrated in high-pressure environment providing explant authorization for Class III implantable devices.
Selected Strengths
• Excellent Customer Service, dedicated to technical excellence
• Experienced in OR and Post-op implantable system troubleshooting
• Device Failure Analysis for hardware and firmware
• Inquisitive and insightful problem solver
• MS SQL Server BI, MS Access and MS Office
Master of Science Medical Device and Diagnostic Engineering
University of Southern California - 2010
Coursework: Engineering Project Management, Structure and Management of Clinical Trials, Introduction to Medical Product Regulation, Biomedical Measurement and Instrumentation, Regulation of Medical Devices and Diagnostics, Medical Product Safety, Quality Systems and Standards, Advanced Studies of the Nervous System, Signal and Systems Analysis.
Bachelor of Science Physics with Biomedical Concentration, Minor in Biomedical Engineering
University of California at Irvine - 2003
PROFESSIONAL CAREER
Boston Scientific Neuromodulation
Data Systems Engineer Nov ’10 Oct '11
-Designed eCRFs using Medidata Rave EDC system for multiple studies
-Programmed Edit Checks into the Medidata Rave EDC system
-Provided technical input to Study Design document
-Generated CRF Completion Guidelines, User Acceptance Testing Plan and Requirements documents
-Extracted patient data from multiple MS Access databases for further statistical analysis as well as R&D and Marketing use
Technical Support Engineer Oct '07 – Oct ‘10
-Managed warranty replacement authorization for implanted devices as the patient base grew to over 40,000 implanted patients
-Developed a rapid investigating technique to identify known device failures, performed over 5,000 device analyses
-Coordinated interdepartmental interaction for identifying the root cause of the device failures and their associated signatures
-Produced failure investigation letters to the physicians
-Coached fellow members of the Technical Support team on the technical aspects of the device failures and patient use patterns
Technical Service Specialist Nov ’04 - Oct '07
-Performed Post-Market surveillance activities as applicable to Technical Support of the Class III implantable product
-Managed 24/7 Technical Support Line for patients, sales team and physicians
-Interacted with Sales, R&D, Regulatory and QA(complaint related) to resolve complex technical issues
-Investigated patient equipment complaints while meeting patients at the clinic
-Mastered the Precision/Precision Plus technology
Beckman Laser Institute
Junior Scientist, June ’03 – Nov ‘04
-Worked on an EPA funded project using the laboratory tools to isolate Live bacteria
-Performed fluorescent microscopy using the LAMMP tools
-Performed rapid PCR analysis for bacteria identification using Ethidium variants
Technician Apr. ‘01–March ‘03
-Supported Laser Microbeam and Medical Program (LAMMP)
-Performed optical microscopy, spectroscopy, data acquisition and analysis for LAMMP users.
UCI Learning and Academic Resource Center
Tutor, Sept. ‘01–Dec ‘02
-Tutored Biology students in Physics using a problem based approach
UCI faculty labs
Lab Assistant
Sept. ‘04 - Dr. Mark Vagins, Department of Physics.
-PMT and photo-insulation installation in Super K neutrino detector. Tayama, Japan.
Aug. to Oct. ‘00 - Dr. Orhan Nalcioglu, Department of Radiology.
-Assembly and troubleshooting of MRI Coils
June to Aug. ‘99 - Dr. Michael Dennin, Department of Physics.
-Assembly and troubleshooting of electronic circuits
Laser Eye Center
Lead Surgical Technician, Nov. ‘97 – Mar. ‘01
-Managed the operating room team with preop, instruments and equipment readiness and post op responsibilities
-Operated and maintained Excimer lasers in optimal condition at multiple surgical sites
-Trained twelve surgeons on Lasik technique, including practice on pig eyes and laser operation
-Assisted in over 20,000 surgical procedures