Nicolas Martinez Email & Phone Number

Columbus, Ne, Us

St Louis, Missouri, United States

Edison, New Jersey, United States

Lead the team in Validation of Medical Devices Manufacturing process, equipment and clean rooms.. Direct, manage, monitor, and control project. • Meet with project stakeholders to understand and refine project scope, Create detailed WBS • Develop and manage the detailed project Gantt chart. Analyze critical path and major workstreams.• Develop a risk management plan for the project.

Horizon City Texas

• Developed, Evaluated and Improved Manufacturing processes & methods• Led lean initiatives Implementation • Established safety & environmental policies as well as a basic documentation control system.• Established a process for Heat treatment system in accordance the ISPM-15

Tijuana Area, Mexico

• led Projects to ensure manufacturability including product costing and validations as per cGMP & ISO 13485/ ISO-11607.• Directs and manage project development from A to Z, defining project scope and deliverables as per established goals.• Responsible for project planning activities, development and control, communications management and progress reports.• Review project plans to plan and coordinate project activity • Control Operational Budget and Expenditures (Capital Investment proposals)

El Paso, Texas Area

• Developed, Evaluated and Improved Manufacturing processes & methods for future ISO 9001 certification• Led the team to a continuous improvement environment/ work force Analysis & utilization, facility layout, and operational data such as production costs, process, flow charts and production schedules.• Led lean initiatives Implementation as 5S, TPM, VSM• Established safety & environmental policies as well as a basic documentation control system.• ** Key speaker in the Engineering Journals at the NMSU with the conference: Wood Packaging & key manufacturing Improvements along the process flow”

• Provided input on DFM as core team member on PDP projects.• Accountable for operations deliverables (RACI): Mfg. plan, Make/Buy, capacity planning, product cost & validations.• Led Application of risk management methodologies such as DFMEA & PFMEA.• Managed contractors & prepare written procedures as per the cGMP/FDA/ISO-13485 guidelines & regulations.• Led Processes & projects thru MS-project tool/ focus in cost reduction initiatives• Conducted problem solving techniques thru: A3 methodology, 8D, Process Mapping or 5 Why methodology.

Chihuahua Area, Mexico

• Led the project teams on new product introductions/transfers. Provided overall leadership & management • Drive out waste through the deployment of Lean methodology.• Supported & maintain project review gates, proactively adjusts budgets and resources as appropriate.• Implemented new process technology & product design on DFM (design for manufacturability) thru DLS system.• Led Maintenance & facilities, Dealing with outside contractors & coordinate facility changes • Establish cost reduction/savings project initiatives thru an appropriate Capital investment policy.• Establish TPM /SMED & Implement OEE, MTTR & MTBF. • Managed Process & Facilities validation in accordance the QSR-cGMP.• Interphase to acquire ISO 13485 certification by TUV –BSI as well as COFEPRIS certification as per NOM 241.• Led Validation of PVC extruder line & plastic injection molding as per product specification requirements• Successfully completed Packaging systems harmonization & validation in accordance The ISO 11607.• Led Implement basic MOST to establish labor standards, line balancing & Layout planning.• BOM structure analysis/ annual labor standard review for budgeting purposes.

Guadalajara Area, Mexico

• led product transfer from Sn. José Ca. & Cleveland OH. To Guadalajara Mx thru NPI Methodology.• Plant Start up to manufacture in a DFT (Demand Flow Technology) environment (Include Mfg. documentation).• Labor quote & product cost for new products focus on DFM. (use of MOST as Work Measurement tool )• Led Process & Facility Validation in accordance with QSR/cGMP. • Floor relocation in accordance CFR 820.70 QSR sect 6 Building & Environment / Interphase to get ISO 13485 certification.• LedEngineering changes (ECO’s) & Capital Expenditures as well.• Led Supplier technical audits to evaluate casting & Machining for Aluminum 356 & A356 based on ASTM standards.• Managed First article validation with Metal casting & machining supplier as per Engineering Specifications.

Ciudad Juarez Chihuahua

• led Product Introduction, processes & equipment transfer Plant 1 & 2• led all safety & environmental affairs in Plant 1 & 2.• Managed building and equipment maintenance, supported Plant I & II ( Breathing &Airway operations) on equipment allocation/Installation & environmental approvals for Startup.• Implemented line balancing & work measurement for proper labor & square footage usage.• Led process validation & product changes evaluation.• Provided 5S training to all personnel as the initial step on lean thinking.• Managed Budgeting for plant engineering & capital investments as well.• Provide compliance education (QSR/ ISO) to the Engineering team to support the overall educational strategies.• Set-up the training center facility, installation of machinery & equipment based on FDA requirements.

Master'S Degree, Engineering/Industrial Management, Title As Master In Sciences Of

Activities and Societies: IIE & PMI during that time member of the Industrial Engineering Institute & Project Management Institute.

Bachelor'S Degree, Engineering/Industrial Management, Title Of Industrial Engineering

Activities and Societies: track & field team Study my bachelor degree as Industrial Engineer & complete my master degree as management.