Luis Salas

Background

About Luis Salas

Industrial Engineer with over 18 years of experience in the medical device industry, leading engineering, quality, supply chain, and project management functions in highly regulated environments. Proven track record in technology transfer, CNC machining, critical cleaning processes (passivation, electropolishing), and new product introduction (NPI) within ISO 13485 and FDA 21 CFR Part 820 frameworks. Successfully led full facility construction and startup, equipment installation, IQ/OQ/PQ validations, and implementation of preventive maintenance systems for molding and machining equipment (including Swiss-type CNC lathes). Delivered projects under budget and ahead of schedule, while supporting customer audits and regulatory inspections with zero findings. Recognized for strategic leadership, hands-on execution, and the ability to build and develop high-performing cross-functional teams. Skilled in CAPEX planning, ERP system implementation (Plex), continuous improvement (Lean Six Sigma Green Belt), and data-driven decision-making. Core strengths: • IQ/OQ/PQ validations • CNC machining (Swiss lathes) • Critical cleaning processes • Technology transfers and NPI • ISO 13485 / FDA QSR / EU MDR • CAPEX project management • ERP implementation • Cross-functional leadership • Lean Six Sigma | DMAIC