Manager of North American Active Devices Product Assessment Team – including experts of Active Implants, Functional Safety, Cybersecurity, Software, and Closed-loop Systems

Manager of North American Active Implantable Devices Product Assessment Team

Product Assessor and Lead Auditor for Class III Active Implantable Devices- Product Expert (Design Dossier/Technical Documentation Reviewer) and Technology Auditor – Pacemakers, Implantable Cardiac Defibrillators, Cardiac Resynchronization Therapy Devices, Neurostimulator, Cochlear Implants, Implanted Drug Pumps, Radioactive Implants- (EN) ISO 13485:2016 Lead Auditor - Electrical and Optical Equipment- MDSAP (Medical Device Single Audit Program) Lead Auditor- AIMDD and MDD Lead Auditor

Manufacturing Engineer for Neuromodulation Division of St. Jude Medical with extensive knowledge of anatomy, physiology, and device interaction. Manufacturing Engineer for the following production lines: Implantable Pulse Generator manufacturing, Non-implanted Electronics Equipment manufacturing, Sterile and Non-Sterile Packaging.Experience: - Trumpf laser TruTops, Quickflow programming, 2D CAD Artwork creation and design - Cognex Automated Vision Inspection Systems with In-Sight - Validation activities (IQ, OQ, PQ, Line Validation, TMV) - Yield improvement and scrap reduction - Process and attainment improvement - Nonconformance reduction - Manufacturing Procedure and Work Instruction development and improvement - Workmanship Standard improvement - Engineering drawings/ Bill of Materials - Design transfer to manufacturing - Production layout change and line move - Tools and fixtures - 5S optimization and Continuous Improvement activities - OUS product configuration management - CAPA team member - Supporting several production lines concurrently - Operator training and certification - Solder techniques and conformance - ESD control activities - Clean RoomCourses/Certifications: - Cognex In-Sight training - Trumpf laser engraving training - Laser welding and resistance welding training - IPC-A-610, IPC-J-STD - Fred Pryor Project Management - Fred Pryor Advanced Excel

Provide independent intra-op and post-op technical support in response to inquiries from physicians, health care professionals, patients and field staff using professional knowledge and judgment. Work to provide the technical interface between the medical community and the various SJM Neuromodulation departments through consultation.

Design and fabricate PDMS devices, study glioblastoma multiforme, neural stem cell, and cortical neuron tropism, migration, and regeneration.

Direct bioengineering summer camp projects, mentor and instruct middle school and high school students in bioengineering principles and experimental design.

Data-mine patient information for retrospective studies carried out by the Trauma Surgeons of Texas Health Harris Methodist Hospital in Fort Worth.