Daniela Osuna Villegas Email & Phone Number

- Validation, verification and sustaining of manufacturing processes for devices regulated by FDA 21 CFR Part 820 and ISO-13485 (Epoxy curing, Micro-sandblasting, Acid treatment, Siliconeapplications, USW, Packaging and others).– Process characterization and validation using statistics tools such as DOE, Hypothesis test(Two-Sample T, ANOVA) and Capability analysis; documenting execution in EngineeringStudies.– Creation and execution of process qualifications: IQs, OQs and PQs.– Direct customer communication regarding manufacturing process development andproduct specifications.– High expertise in engineering changes software, like ETQ Reliance, and a lot of experiencewith ERP platforms like Oracle and SAP.– Owner of the production line manufacturing process capacity: headcount, line balance, equipment constrictions, shifts and overtime needed.Projects:– Manufacturing process development for an electronic implantable device per customer’sspecification: Silicone applications with XYZ arm robot, Ultrasonic welding, Pressure test,Pull test and others (before market release).

- Experienced with FDA inspections as document reviewer.- Engineering lead during ISO and internal audits.- Creation of manufacturing documentation for new products: manufacturing routes,instructions and forms, BOMs, production flow diagrams and DMRs.- Manufacturing assessment owner for creation of PFMEAs and PCPs of new part numbers.- Experienced in root cause analysis tools and A3 template for SCRAP and rework trends, Non-Conformances and CAPAs.Projects:– Introduction of 1st electronic implantable device fully build in Mexico transferred fromUruguay.– Cost saving projects and customer changes to improve supply chain (supplier change),production cost and process performance (Rework and SCRAP).– Designed a daily production monitoring program using VBA. The data of +60 users is collected for analysis: rework and SCRAP trends, FPY, production plan, productivity and current status of every work order in the production line.