A successful, talented and hard-working Industrial engineer with extensive experience in process management, process validation and project management for the medical devices industry, who always perseveres to achieve the best results. Able to collect and analyze information and quickly grasp complex technical issues. Excellent negotiation and problem solving skills, focused on swiftly identify the root cause of any problem and develop an effective solution. Proven ability to manage and complete project to the highest standard, with a meticulous attention to details and within agreed deadlines. With wide knowledge on management and lean manufacturing implementation.
•Defined and created a master validation plan to properly define an effective strategy to validate more than 385 equipment insuring compliance to meet FDA regulations, achieving satisfactory feedback during corporate and supplier audits avoiding findings.
•Experienced subject matter expert in charge of validations, responsible to defend engineering requirement during FDA audit. Created a plan to ensure Quality system readiness ensuring no observations identified during the last FDA audit.
•Created and implemented a project reporting/tracking system (Balance Scorecard) that provide visibility to the middle management in order efficiently coordinate resources, define priorities and evaluate projects progress.
•In charge to conduct weekly meetings with the quality and manufacturing department, establishing clear and effective communication lines, providing constant feedback related to opportunities of improvements in the production floor identified by the quality technicians, this meeting guarantee and promote continues improvement and constant compliance in the manufacturing processes.
•Created product /process control plans that meet supplier requirements ensure a clear system to define accurate manufacturing process control.
•Trained and coached the engineering team in effective process validation techniques improving the lead time of protocols completion.
•Lines transference project leader: in charge to define transference logistic, create capital budget, coordinate domestic and international resources, follow up on project task completion and define resources required to complete the projects implementation.
•Developed and monitored risk mitigations plans to ensure business and project objectives were accomplished on time.
•Designed new packaging configurations and developed several projects for new raw material introduction (Direct seal) obtaining savings of 2M dollar FY11 and FY12.
•Designed new packaging tooling and machine stations to increase throughput, reduce waste and material cost.
•Established new test methods and completed process risk assessment, reducing the probability of misclassification of finish product.
•Successfully developed and implemented validation projects related to process improvements in the manufacturing, Molding, packaging and print shop areas, achieving substantial production cost reduction over US$500K.
•Significantly cut waste of material on manufacturing area producing savings over US$400K by increasing the usage of a high cost raw material.
•Handled and implemented six sigma tools in process improvement project accomplishing process standards.
•Created improvements projects involving line balance and layout to eliminate products backorder in a 100%.
•Performed daily reviews of process Key Performance Indicators (“KPI”), complete material variance, labor variance, efficiency, inventory reports involving root cause analysis and corrective action plan to achieve company metrics representing savings over US$200K.
•Managed and created continues improvement team in charge to evaluate, analyze and improve key process inputs and outputs obtaining significant improvement in the efficiency from a 65% to 95%.
•Performed kaizen events, accomplishing goals of overhead and change over reduction, at the same time being recognized due to the outstanding effort in the successful implementation of a Kaizen at the manufacturing area.
•Validated the plastic Molding process establishing the correct operational windows for the process reducing the scrap level in a 40%.
Advanced coursework in Lean/Six Sigma Coaching
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