Mayli Lagunas Email & Phone Number

Tijuana, Baja California, Mexico

- Coordinate MDR projects, establishing timelines, coordinating activities with internal and corporate personnel.- Responsible for carrying out the gap assessment, in accordance with the MDR regulation requirements, to the documentation provided in technical files of products certified with MDD, in order to carry out activities for compliance with new MDR regulation.- Propose and review design validation and verification strategies with marketing, regulatory and R&D team.- Coordinate and execute design validation and design verification protocols.- Responsible for updating drawings, process flow diagrams, Master Validation Plans, as well as other process documents.- Responsible for creating or updating the design input and output matrices, as part of the development procedures.

-Responsible on administration of human and material resources assigned to Sustaining Engineering. -Responsible for documentation of manufacturing process (Work instructions, visual aids, procedures etc.)- Coordinate and execute validations (ES, IQ, TMV, OQ, PQ)- Risk analysis and improvement implementations- Project management, establishing timelines

Tijuana Area, Mexico

Work directly on the product development including the following responsibilities:- Design of the final product, packaging design, Instruction for use and define product specifications, as well as internal and external requirements.- Coordinate and perform design validations, clinical studies, biocompatibility tests, packaging validations, stability test, aging studies.- Design of manufacturing process, and new product introduction (BOM, routes, part number creations, process and fixtures design).

Provide support to the introduction of new products which consist in the validation of new semiautomatic equipment, elaborating documentation such as protocols and reports of Installation Qualification, Operational Qualification and Performance Qualification. Also the elaboration of the following: Engineering StudiesFactory Acceptance Test (FAT)Site Acceptance Test (SAT)Process Failure Modes and Effects Analysis (PFMEA)Change assessmentsChange requirementsDesign of experiments

Provide support for the engineering evaluation of materials for the Multivac packers. Coordination of engineering samples, functional tests, shipping and quality failure analysis.Participation in transfer Project of automated machines from Ontario, CA. to the Tijuana location, performing Installation Qualification, Operation Qualification and Performance Qualification, Capability tests, Design of Experiments , Design and analysis of Gauge R&R test and Engineering Evaluation. Redaction of documents for Software Validation such as User & Functional Requirements, Test Scripts, Validation Protocols and Test Results.Analyze output variables of the Ultrasonic Welding to calculate the minimum and maximum acceptance limits.

Diploma Of Education, Six Sigma Green Belt

Diplomatura, Medical Industry

Industrial Engineering

Industrial Engineer with a specialty in Automation and Control.