Luis Alba Email & Phone Number

Engineering Professional with 10+ years of experience in the medical device manufacturing sector, with main focus in New Product Introduction, Process Development, Mechanical Design / Automation, Process Validation and Process Improvements. Certified in Lean Six Sigma Green Belt (LSSGB) and as Solidwork Professional (CSWP).Extensive experience in the following areas:* New Product Introduction through gated Project Management Process.* Class II and III medical Device Manufacturing.* CAD for Design of Fixtures and Equipment.* Industrial Automation.* 21 CFR Part 820 and ISO 13485 standards.* Process Validation - MVP, URS, FAT, SAT, IQ, DOE, OQ, PQ, PV, TMV, Software Validation.* Medical Device Life Cycle, Design Control and Change Management.* Lean Six Sigma.* Root Cause Analysis and Problem Solving.* Data Analytics.