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Click here or scroll down to respond to this candidateMOBILE PH. PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLELocation: Thompson, CT. Street Address
Candidate's Name
SummaryElectronics Engineer with a diversified background as Program/Project Manager, New Product Introduction and Engineering Management in a client-oriented environment. Manufacturing and Process Development conducting Process Improvement Projects within the Medical, Electronics and overall manufacturing industry. Planning and conducting tests to validate equipment and processes. A technical minded individual known for improving procedures and productivity, scrap and cost reducing and to prevent safety problems. Works well under pressure both independently and as part of a team in a deadline driven, fast paced environment.Project / Program Manager - Coordinator - Team LeaderNew product Introduction & Process DevelopmentProduct life cycle and testingLean manufacturing & Continuous improvementReliability EngineeringProfessional Experience11/23 to Date The University of Massachusetts, Amherst, Massachusetts.Contracted 12mo. thought Actalent agency.Position: Cleanroom - Core Facility Operations Manager.Im currently working in the Institute for Applied Life Sciences (IALS) as the Device Fabrication and Nano Fabrication Cleanroom Operations Manager and I have been working closely with IALS (Institute of Applied Life Sciences) Core Facility Director: Mr. Andrew Vinard and the R2R Fabrication Facility Director, Dr. Jeff Morse, to review and establish Cleanroom Operating Protocols.Im Leading the daily technical and administrative operations, maintenance of equipment, training and supervision of users, ensuring a smooth and seamless transition for compliance with UMASS Lab Safety and general Environmental Health and Safety Protocols. As part of my role as Cleanroom operations Manager, I am organizing several changes in cleanroom protocols and tracking, maintaining record of users in the Device Fabrication and Nano Fabrication cleanrooms, organizing and tracking of daily supplies and chemicals for the cleanrooms usage, keeping the cleanroom equipment operational in order to enable all users to make advanced micro/nanofabrication specimen samples and processes. I am collaborating with UMASS faculty, staff, students and outside users to optimize your time while maximizing the high impact research output of the cleanrooms.I have been planning and conducting tests to validate or re-validate Core facilities equipment and processes. A technical-minded individual known for making improvements in procedures and in productivity, scrap, cost reducing and help preventing Safety problems.10/22 to 09/23 Putnam Plastics Corporation (PPC) (Biomedical), Dayville, Connecticut.Position: Process Development Engineering - Program Manager.Medical grade Plastic Components and Plastic single, double or triple layer tube Extrusions both wired and non-wired Braided, for Medical Devices, Catheter Sub-Assemblies and bonded, flared, lathed and Drilled Medical Components in a ECR (Environmental Controlled Room), White Room or Clean Room Class 5,6,7,8 Facility, focusing on Continuous Improvement Processes & GMP.Key contact responsible for coordinating NPD (New Product Development) Equipment, Product, Process and/or Technology transfers to the Production Group for Production Scale up of medical Components Supplied to Medical Device Companies with compliance standards for FDA CFR Part 820 and ISO 13485 / EU MDR.Owner of Current and future Production System Analysis of conditions to help Scale up Production by Integrating Systems and implement Hardware and Software solutions.Provided clear written and verbal instructions to Process Development group to identify any potential barriers for the timely execution of the product/orders for on-time delivery and promptly addresses any team member questions or concerns.Efficiently delegated tasks, encouraging teamwork while assigning responsibilities to team members, outline goals, ensuring group members understand whats expected.Reliability Engineer for Manufacturing and Production specialist to study equipment life cycle and performance analysis to inform how business invests in for current and future needs and technology road maps and maintains equipment assets.Processed supplier nonconformance issues through SCAR investigation, coordinating with suppliers to facilitate product containment, root cause analysis, corrective preventive actions, and verification of effectiveness.Reviewed nonconforming Products through Production stages utilizing PFMEA, SFMEA and 6M analysis tools to determine risk criticality, impact level, and disposition method.Applied Six Sigma Quality tools and Methodologies like DOE, DMAIC, FMEA, RCA, Pareto Charts, Fishbone Tool to Identify Potential Risks, support innovation, Continuous Improvement of business processes by reducing defects and errors, minimizing variation, and increasing quality and efficiency.Performed Engineering IQ OQ PQ to validate new Equipment, Revalidation, Prospective and retrospective validation and Cleaning Validation to demonstrate cGMP.cGDP for Work Instructions, Set-up and other critical Documentation review for accuracy, educate & correct accordingly, highlight process gaps for tighter Control.Installed Rotronics Monitoring System (RMS) Temperature and Humidity Loggers for Raw Materials Humidity Content Studies for extrusion Processes.Worked with internal Departments and groups to identify gaps and variations in Manufacturing processes and Vendor Supplied Materials.Performed the role of subject Matter Expert (S.M.E.) for NCs (Non-conformances) and CFs (Customer Feedback) for Product, Process investigations.Assisted QE with CAPA Meetings, Kaizen Event Coordinator to address and identify potential problems areas and Process Continuous Improvement Solutions concerning Production improvement opportunity areas.Mentored all employees, with honest, respectful, ground and effective communication and provide employees clear and understandable production / quality / safety concerns.Dealt with conflicts in a constructive manner, listen to all sides and seek to resolve.Protected confidential information that is being disclosed during employment.01/21 to 09/22 L&T Technology Services LTD. Edison, N.J. Sr. Enterprise Management Engineer, trained in Medical Devices and Components Code of Federal Regulations, FDA regulatory, ISO 13485, to work on new projects within Medical field as External contractor.External Contractors to Cytiva (Danaher Group), Marlborough, MA. (10/21 to 09/22)Position: Sr. Manufacturing Engineer.Global Biotechnology Manufacturing engineering, Class 5, 7 & 8 Clean Room specialist,Remediation Team coordinator, Work Instructions reviewer & Continuous Improvement.Reviewed and analyzed purchase specification documents for nearly 2100 components to modify attribute notes and adding component drawings.Utilized Gage R&R technique to evaluate and improve measurement system used for Hollow Fiber cartridge measurement process.Equipment Validation using IQ, OQ and PQ for Hollow Fiber Assembly equipment for potting, Oven curing and Annealing, Epoxy cutting, Cartridge chamfering and Cleaning Validation for washing and drying equipment for medical device compliance standards of FDA CFR Part 820 and ISO 13485.Investigated supplier parts with minimal nonconformance and complaint history to qualify for Dock-to-Stock, thereby eliminating the need for receiving inspection and saving thousands of dollars in labor costs.Utilized statistical analysis tools such as Six Sigma and DMAIC to make investigations.Updated component qualification documents by revising part drawings, inspection procedures, and capability requirements to support the implementation of supplier change request (SCR) action plans.Worked with a Team to identify gaps and variations in manufacturing processes as part of daily GEMBA keeping changes using Microsoft Projects for effective tracking.Reviewed HF filtration cartridge assembly processes in the clean room to identify process gaps and ensure associates follow assembly procedures as per W.I.Participated in 5 Kaizen events to identify potential problem areas and process improvement solutions concerning assembly of Hollow Fiber cartridges.Generated Engineering Change Requests and Engineering Change Orders for changes on standard, Designed Components for Xcellerex, Ready Circuits and bioprocess bags.Transitioned documents from Magic (Old MES) to Veeva Vault Repository (MES).Worked cross-functionally with Quality Assurance, Engineering and Manufacturing for Document Change Control process for Hollow Fiber work instructions for impact assessment in Veeva MES system.09/18 to 11/20 BD-Becton Dickinson Medical Device Company, El Paso, Texas.Working 1-year contract and extension with Manpower as external contractor.Position: Lead Mechanical - Electrical Product Engineer.Antiseptic Chloraprep formulation for applicator products used on Surgical and Surface skin preparation, Equipment Repairing and Troubleshooting, in a High-speed Automation Equipment, Plastic Assemblies with Glass Ampules using Ultrasonic Welding in Plastic components and foam for Medical and Pharmaceutical Devices and the use of Linx and Dominos high-speed printing.Provided technical support with design and troubleshooting of automated manufacturing equipment to ensure Safety, quality, delivery and so that Cost Metrics are achieved.Applied technical knowledge to do troubleshooting in the manufacturing process.Developed Manufacturing Process by designing and modifying equipment for building and assembling Electrical Components, soliciting observations from Manufacturing personnel.Maintained products & company reputation complying with federal and state regulations.Kept equipment operational by following Manufacturers Instructions and establish Procedures, and Repair Service Requests.Equipment Validation IQ, OQ, PQ, and Process Validation Method & Control.Maintained Project Documentation Prints, Manuals, Programs and SOPs.Worked with conjunction with other Teams in product launch teams as well as OEMs to review issues and Develop Solutions, Machine validation and Run Offs.Leaded C.A.P.A. (Corrective and Prevention Actions) to address Systematic issues in the Manufacturing and Quality systems.Developed Electrical and Mechanical B.O.M. (Bill of Materials) to Control Design/ Creation Panels researching for Supplier Products for components Assembly.Controlled and developed all aspects related to Safety Procedures and Identify the necessary Adjustment to address potential Safety Concerns, including the proper use of P.P.E.Developed Technical and Production Staff by conducting Training to help the teams to increase their technical skills and Knowledge of the Manufacturing Equipment & Products.Performed the role of subject Matter Expert (S.M.E.) in Development, Troubleshooting and Maintenance of equipment within the organization.10/16 08/18 MICROTECH, El Paso, Texas / Jurez, Mxico.Position: Sales & Operations Manager.Coordinated Sales, Maintenance & repairs of all types of electronic equipment & parts locator supplier for Manufacturing industry clients in the border area.Recycle of ink & Toner for laser Printers, Copiers, and fax cartridges and diverse office supplies for the Manufacturing industry.Computer / Laptop equipment sales, installation of industrial equipment and accessories.Rep. Human Resources, Program Planning, customer service and troubleshooter.01/12 09/16 IMS / VIASYSTEMS, El Paso, TX. / Jurez, Mxico.Position: NPI and Product Engineer Dept. Coordinator promoted to Program Manager.Telecommunication chassis Assembly, NPI Department Coordinator and later as Program Manager for worldwide telecom companies like Tellabs, Lucent, Alcatel, Sycamore, Performance Technologies, & Occam communication. Reporting directly to Plant manager.Coordinated new product introduction from U.S. to Juarez plant.On Time Cost/Delivery by preparing milestones, production schedules & prod. Forecast.Worked closely with project teams to identify issues and risks resulting in cost effective new product development and introduction.Served as S.M.E. to develop manufacturing work instructions enhancing quality in operations.Prepared ECO, BOMs QDA, DEV and NPIs, Productivity and Efficiency Responsible.Leaded daily PDCA Meetings with Reports, flow Charts and Visual Aids.PFMAs for developments for scratched or damaged components and visual defects feedback and analysis reports.Six Sigma, 8 Ds, SPC Lean manufacturing and 5 S enforcer.Collaborated with PD defining preventive maintenance programs eliminating down time 10%.Improved efficiency by 5% by redefining layout and workflow.04/07 12/11 WISTRON DE MEXICO, El Paso, TX / Jurez, Mxico.Position: NPI Dept. Coordinator, Promoted to:Engineering Manager for 2 years and Manufacturing Manager for 1.5 years.Server NPI (New Product Introduction) Department supervisor and NPI for Sun Micro systems servers and Nortel IP voice Phones. Reporting directly to Plant manager.Productivity and Efficiency Responsible, daily PD Meetings and Reports.WIP analysis, flow Charts and Visual Aids.Production schedule enforcer, Forecast vs. Manpower analyzer.Quality workmanship scratched or damaged components and visual defects feedback and analysis reports.Six Sigma SPC enforcer, PD-HR Promotions and permanent worker final approvals, overtime schedule and approvals.Monitored timelines & project deliverables achieving on time delivery 10 consecutive months.Scrap reduction by 15% (Setup training and visual Aids).10K USD savings by developing & improving preventive maintenance programs for machinery.Improved OEE by 15% by implementing standard work programs for direct subordinates.Managed personnel to increase productivity by 40%.01/94 04/07 4 more previous Jobs.EducationCertifications1990 1994 The University of Texas at El Paso. (El Paso, Texas, U.S.A.)Bachelors Degree in Electrical Engineering in computer option.1988 1994 Technological Institute of Juarez Mexico.Bachelors Degree in Electrical Engineering with major in Computer Systems.Introduction to Program Management, the Basics of Project Management, Teams & Leadership, Project Communication, stakeholder Management, Scope & Requirements, Life Cycles, Effective Budgets & Schedules, Project Performance, Change Management. NFPA 70E Electrical Safety and ISO13485:2016 Requirements.SkillsReferencesLanguages: Bilingual English-Spanish written and spoken.Analytical & Critical thinking, Problem Solving, Leadership, Project & Time Management, Data Analysis, Process Development, Project/Program Manager and Coordinator, Team Leader, NPI, Product life cycle and testing, Lean manufacturing, Continuous improvement and Reliability Engineering. Management, Communication, Adaptability, Organization, Decision Making, Conflict Resolution and Negotiation, Work ethics, Teamwork, Collaboration, Customer Relationship, Use of Available Technology, Active Learning, Emotional Intelligence, Work Under Pressure, Empathy, Flexibility, Work Independently and Attention to Details,Equipment: Digital Microscope, Surface analyzers, Instron, Oscilloscope, Multimeter, Insight Explorer for 2D-3D cameras, wide spectrum using Mechanical tools.Office: MS Office 2016, Office 365; including Word, Excel, Power Point, Access, Projects, Outlook.MES: TPS, Flow DEF, TRS, SAP, HP Agile System, Magic, Veeva, Siemens OP Center, QAD & CEBOS.Upon Request. |
