Sergio C. Email & Phone Number

Medical Device Industry professional with 17+ years of experience in the manufacturing of Class II and Class III Medical devices. Proficient in Project planning & execution. Experience in development of process/product costing. Experience in Project management involving coordination of cross-functional teams (site & customer). Writing and editing of technical documents such as Engineering Studies, CO, validation/qualification (protocols and reports - MVP, IQ, OQ, PQ & PPQ), Risk Assessments. Proficiency with hands-on design of experiments and the Six Sigma methodology. Lean manufacturing acquaintance. Self-driven work and research. Results oriented professional. Experience in the transfer and validation of semi-automated assembly lines. Interpretation of drawings. Experience with Value Stream Mapping and PFMEA. Software: MS Office (including Project), AutoCAD, SolidWorks, Minitab; acquainted with Oracle. Proficient in Root Cause Analysis techniques. Acquainted with ISO 13485-2016 and FDA regulation. Fluent Languages: English, Spanish