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.

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.

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.

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.