Thomas Avery
R & d Engineer Ii @Balt Usa
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WORK HISTORY
R & d Engineer Ii @Balt Usa
Irvine, CA, US
Lead the development, clearance, and launch of two embolization coil platforms (neurovascular and peripheral), contributing to $40M+ in annual revenue, including co-authoring two FDA 510(k) submissions (both cleared)-Author and execute Design Verification Testing (DVT) protocols and reports for proprietary embolic coil geometries, while supporting verification for stents, guide catheters, and aspiration catheters-Update and validate risk management documentation (FMEA, risk matrices) and manufacturing processes in compliance with ISO 14971 standards-Resolve two NCMRs including reinspection, lot segregation, and development of a novel compliant rework procedure; supported CAPA corrective actions-Spearhead cross-functional root cause investigations on field complaints (e.g, catheter failures), presenting findings directly to executive leadership-Mentor R&D, Quality, and Process Engineers in coil design principles, risk management, and process controls.
EDUCATION
UCLA
Bachelor of Science - BS, Mechanical Engineering
ABOUT THOMAS AVERY
Results-driven R&D Engineer with experience leading the development and clearance of Class II implantable devices, including embolization coils and structural heart technologies. Proven track record of authoring 510(k) submissions, executing design verification protocols, developing test methods, and driving cross-functional initiatives across R&D, Manufacturing, and Regulatory Affairs. Skilled in neurovascular and peripheral vascular device development, manufacturing process validation, and risk management (ISO 14971). Passionate about delivering innovative, procedure-critical technologies that advance patient care.
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