Sevan Oungoulian Email & Phone Number

San Francisco Bay Area

San Francisco Bay Area

▪ Contributed to successful FDA IDE (Investigatory Device Exemption) of novel drug-coated balloon catheter (combination device); approval received within 5 months of submission▪ Contributed to successful CE Mark approval of two novel drug-coated balloon catheters▪ Generated design (DFMEA) and process (PFMEA) risk analyses based on ISO14971 standard▪ Trained and managed 4 operators and 2 engineers in the performance of design verification and validation testing and implementation of process improvements.▪ Performed design and test method verification / validation per ASTM / ISO / FDA guidance▪ Authored process documentation (MPI, LHR), test protocols, test reports, & regulatory submissions.▪ Utilized DOE to evaluate coating process changes; executed testing of design changes ▪ Produced stability testing documentation following design controls, cGMP and ICH guidelines.▪ Supported initial draft of new ASTM guidance on drug coated balloon test methods ▪ Designed and fabricated devices for use in development and manufacturing facilitating process improvements and yield increases: ▫ Drug coating thickness and integrity testing based on FDA feedback ▫ Modified apparatus 7, per USP711 for in-vitro elution testing with third-party vendor ▫ Solid-state surface cleaning of nylon balloons ▫ In vitro model and particulate release testing as a measure of manufacturing repeatability

Greater New York City Area

▪ Submitted successful proposals; completed 3 engineering design and build projects▪ Worked directly with customers to develop and implement device design specifications▪ Designed and fabricated devices for use in research and development: ▫ Injury device for impact studies of neurons in monolayer (traumatic brain injury) ▫ Optical subplatform for high speed laser imaging with diamond nano-particles ▫ Auxiliary components for a stereotaxic platform used in Gamma Knife radiosurgery

Greater New York City Area

▪ Characterized chemically fixed articular cartilage xenografts for use in cartilage repair▪ Evaluated use of modern particulate characterization equipment as a tool for arthritis diagnosis▪ Developed a non-contact technique to measure mammalian egg cell zona pellucida properties▪ Assisted with grant submission resulting in long-term biomedical/mechanical engineering research▪ Managed and mentored 15 graduate and undergraduate students▪ Designed and fabricated devices for use in research and development ▫ Microfluidics device to capture and maintain position of mammalian egg cells during imaging ▫ Bone clamp to secure joints within a sterile field while allowing a wide positioning range ▫ Tissue imaging setup to simultaneously image top, left, and right sides of tissue samples ▫ Phosphate buffered saline sterile filtration device ▫ Friction testing device providing multiple degrees of freedom and frictional measurement ▫ Sterile cartilage tissue grinder for generating large quantities of cartilage wear debris ▫ Custom electropolishing cell for metallic components used in joint replacement implants

San Francisco Bay Area

▪ Contributed to design and prototyping of a next generation guidewires for neurovascular coils▪ Evaluated prototypes using internal and ASTM test methods and FDA regulatory guidelines

Doctor Of Philosophy (Ph.D.), Mechanical Engineering

Master Of Science (Ms), Mechanical Engineering

Graduate Teacher Assitant, Biomechanics Lab, 2006 Department Award for Academic Excellence, M.S. 2007 Graduate Student Representative.

Bachelor Of Science (Bs), Mechanical Engineering