Yudihect De Los Santos Villaman

• Partner with Sutures Plant Leadership Team to manage short & long-term vision and execution plans for the Operational Excellence function at the plant
• Manage Medtronic Performance System deployment and maturity across the site (~ 4,500 Employees & 3 Shift).
• Coach, educate, and build organizational capabilities as defined within the Medtronic Performance System global operational excellence program.
• Lead Sutures cost reduction program targeted at reducing operational costs by 5% yearly for labor, burden and material.
  Drive implementation of Operating Mechanisms across the site (Strategy excellence, Policy Deployment, Tier Daily Management, TPM, 5’S, Value Stream Excellence).
• Manage Site Lean Sigma Training & Certification Program (Yellow Belt, Green Belt & Black Belt) with + than 50 Yellow belt & 10 Green Belts certified during last FY23.
• Deploy team Business improvement engineering resources across the site to support continuous improvement activities and leverage lean manufacturing capabilities to drive operational efficiency and lead time reduction.
• Manage CAPEX for value Stream excellence strategy. + USD Dollars 800K
• Leader of the Quality Culture Program implementation "Put Patient First" for the Site with an OHS survey engagement results of 97%.
• Black Belt coach for complex business case resolution through the DMAIC tools daily usage.

Key Achievements leaded and or support:

• Material Scrap Reduction by 9.2% of loss allowance & USD$734K Cost savings through inspection optimization and do not make control project implementations.
• Labor improvements projects & productivity increase by 25%, reduction of the labor COP by 13% through change over improvement and balance optimization projects.
• Space reduction by ~6000 SQF and USD $2M of cost avoidance
• Lead time/ WIP Reduction by 15 days and + USD $1.5MM WIP avoidance. (LSSBB Project)
• More that 60% of the process transform to cells within a lean environment delivering +25% of productivity, No Costumer complaints, Several cost reduction and all employees involved in DMAIC problem solving daily execution (Cultural change) (GB Project)
• Coach of the Manufacturing Schedule adherence KPI with an improvement from a baseline on FY22 of 60% to a current performance of 90% as of FY23.

-Support Operational Excellence programs and efforts for short and long-term goals

-Manage Site Lean Sigma Certification Programs (Yellow Belt/ Green Belt/Black Belt) and assure resources are leveraged for site continuous improvement activities

-Responsible for Operational Excellence training programs and events at the Focus factory (DMAIC, A3 Problem Solving, PMP, Lean Sigma, First Time Quality, etc.) Assuring training and events support site goals for continuous improvement

-Lead plant improvement projects of significant size and scope, such as high impact process transformation from traditional line to cell operating system, Flow & Pull connect strategy lead for absorbable sutures with a improvement from 35 to 22 days @Lead time & Quality improvement (Low Needle attachment) project coach with zero NCRS & Complaints

-Lead the coordination and deployment of the Operational Excellence plan for Cell Operating System (COS) and Medtronic Operating System (MOS)

-Lead / coach COS conversion teams through COS playbook activity for successful a “Go Live”/ Implementation results

Assist leadership in establishing baseline and target metrics for key processes

-Support the Operational Excellence Principal/ Manager in the overall deployment of OPEX training, best practice sharing and in mentoring project teams and leaders

-Lead quality begins with me visual management workstream.

• Manage Operational Excellence programs and efforts at the focus factory for short and long-term goals achievement assuring culture and systems development in support of continuous improvement in cost and quality performance
• Lead plant improvement projects
• Lead / coach COS conversion teams through Cell Operating system activity for successful a “Go Live” results
• Lead/coach manufacturing process design including: First time quality, equipment design, motion/ ergonomic assessment, and process subsystems integration
• Facilitate Lean events to support site strategy including cost reduction.
• Drive Operational Excellence project completion to meet program goals
• Develop training programs and systems for implementing and sustaining site CI strategy
• Establish and evaluate with the management team the goals for the site yearly plan
• Provide subject matter expertise on the plant’s manufacturing excellent program
• Promote and communicate activities, results, and best practices throughout the organization
• Lead of “Continues improvement champion certification” development and implementation to promote a culture where the supporting and operating groups have understanding regarding problem solving tools through the DMAIC methodology
• Cell operating system process implementation for sutures Abs and Non-Abs Value Streams, with more than of 500K saving, and improvement @Lead time, Productivity, MUV and quality improvement in a 50% approx.

• Ensures that suppliers deliver quality on raw materials
• Lead supplier quality beings with me program (Supplier’s excellence)
• Q Leadership Award for QBWM program implementation at Vention PR & Medplast Tempe
• Qualifies suppliers according to company standards
• Monitor parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur
• Evaluate suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation
• Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products
• Lead customer complaints related to suppliers to ensure adequate corrective actions are taken
• Manage Supplier CAPA program to ensure proper corrective actions
• Responsible for raw material assessment and transfer process between sisters’ plans, including equipment and methods validation for inspections.
• Support and approve raw material deviations process
• Ensure proper approval are followed in any process, material, or tooling changes (SCR) at suppliers
• Manage Production Part Approval Process (PPAP)
• Evaluate Manufacturers performance; recommend and support the implementation of continuous improvement activities within the supplier quality systems based on evaluation
• Supervise and lead operational activities of devices Incoming area
• Perform supplier process CI visits and evaluations to ensure compliance with Medtronic process
• Lead of Ship to Stock program with cost reductions generated year over year
• Lead new system process for raw material deviation when applicable.

• Provide recommendations for product disposition or other actions related to product nonconformance
• Test method validation and New Product Transfer process support.
• Nondestructive air leak test method validation, avoiding cost due to total lot scrap when rejected (Leak) & Porosity test implementation for packaging material with a lead time reduction from 5 to 1 day
• Non-Conformance investigation and validation protocols approval
• Responsible to guarantee that the new and existent process, material and product meet the quality requirements established, assuring also the compliance with ISO 13485 and 21 CFR Part 820
• Internal audit execution and external audits support.

• Non Conformance Issues root cause Investigation
• Responsible for rejected product evaluation and final disposition
• Responsible for the inspections across two value stream and 11 QC inspector.

• Supervise calibration area (2 Technician)
• Technical support to engineering department in validation process
• Nonconformance and out of specification investigations related to calibration process
• Lead calibration strategic projects: Calibrations migrations from external supplier to internal system @ 70% (150 assets approx.), achieving cost and lead time reduction.