PROFILESenior Quality/Manufacturing Engineer with Product Development, Process Engineering, Project Management and Leadership Experience.Experience is inclusive of Product Development, Product Quality Assurance, Develop and Implement Product Quality Plans. Product Specification, Quality Specification. Product Requirements. Risk Analysis FMECA, New Product Transfer, Product Launch, Work in conjunction with multiple cross functional teams from product design input/output to product submission/launch/transfer, manufacturing process development, operations sustaining, continuous improvement, root cause failure analysis (CAPA), and project management such as new product introduction, continuous improvement, gross margin improvement, successfully multi-task projects, prioritize deliverables, communicate results, and manage cross-functional team resources to solve problems and ensure that projects are implemented on time, within budget, and in compliance with quality and regulatory requirements.PROFESSIONAL WORK EXPERIENCEOverall Experience: Product Development Quality Assurance, Product Performance Qualification (PPQ), Master Validation Plan (MVP), Inspection Test Plan (ITP), Design Reviews, Project Management (NPI, GMI, CI), Cross-functional Team Management, Engineering Team Management, Equipment & Maintenance Management, Process Qualification/Validation (IQ, OQ, PQ, TMV, IMV), Process Characterization & Development, Design of Experiments (DOE), Test Method Validation (TMV), Capability Studies, Gage R&R, Risk Management Process & Design FMECA (ISO 14971), Statistics & Minitab, Designing for Lean Manufacturing Sigma Green Belt, Process Controls (SPC), Tooling and Fixture Design Improvement, SolidWorks and GD&T, Tolerance Analysis, Root Cause Failure Analysis & Investigation (CAPA), Manufacturing Cost of Goods (COGS), Regulatory Standards FDA 21 CFR Part 820, ISO 13485 and 9001 QMS, and ISO 14001. Excellent verbal & communication skills to communicate to all levels of organization. Collaborate with Manufacturing, Quality, R&D, and Regulatory. Mentor younger engineers.EDUCATION & CERTIFICATIONSB.S. Electrical Engineering, Graduate Cum Laude, GPA: 3.6, Texas Tech University6 Sigma Green Belt, Villanova UniversityManufacturing Operations & Supply Chain Management, APICS North Texas, Certificate6 Sigma Statistical Process Control Masters Series, CertificateDesign of Experiments III, CertificateLeading with Impact, Certificate