SUMMARY

• Design, Project, Configuration, Quality, and Manufacturing Engineer with diversified experience in the formulation, design, configuration, development, analysis, testing, automated / chemical process, and/or modification of products, equipment, and facilities, emphasizing medical (FDA) and defense applications requiring validation (IQ, OQ, PQ), performance, system/assembly troubleshooting, heat transfer, stress, and structural analysis.
• Career encompasses significant background in computer modeling and computer - aided design (FEM). An effective staff member and project/team leader with a unique blend of technical, communicative, quality, and managerial skill, a strong commitment to achieve objectives as established, and the capacity to utilize and coordinate efforts of a broad array of internal and external resources in the timely completion of projects. Holds M.B.A degree in Management, Master of Engineering degree in Mechanical Engineering, and B.S. degree in Mechanical Engineering. Held Secret Clearance
• Planed, scheduled, coordinated, and supervised a group of engineers and designers that supported the generation of new drawings / documents, and updates to existing ones.
• Coordinated and supported the closure of pending Corrective Action reports (CAPA).
• Analyzed and organized operations, instituting procedures and controls over aspects of operations including research, development, design, testing, and documentation.
• Ensured operational and project compliance with established performance, quality, health, safety, and regulatory standards.
• Assembled and guided personnel in accomplishment of team objectives, directing technical development, testing, and modification efforts.
• Active member of the Lean Manufacturing Engineering groups.
• Developed Master Plans, along with the validation protocols, and reports.
• Member of the Core Teams for Cost Savings / Process Improvements.
• Supporting Transfers of process projects and equipment to Mexico and Costa Rica.
• Developed operational procedures and conducted training and staff development programs.

PROFESSIONAL EXPERIENCE

Confidential, Palm Beach Garden, Florida

Manufacturing and Validation Engineer

Responsibilities:

• Confidential is a leader in the development, manufacture and sale of medical devices of orthopedic, joint replacement and Dental Implant / Abutments.
• Supporting the Transfer projects from Carlsbad California (CCA) to Palm Beach Garden (PBG) FL.
• Supported Transfer of Dental Implant and Abutment machining from CCA to PBG.
• Supporting Transfer of Cleaning line processes from CCA to PBM for dental abutments and implants.
• Develop and execute Process / layout design.
• Released drawings, and procedures for new process in PBG facility, following the guidelines of FDA, ISO, and GMP.
• Generated protocols and reports to execute IQ, OQ, and PQ validations.

Confidential, Tualatin, Oregon

Manufacturing Engineer - Engineering Department

Responsibilities:

• Core Member in the Costa Rica Transfer Team. Ensuring that process / equipment transfers are complete with documentation, process, tribal knowledge, and required equipment / tools.
• Learning and understanding Creganna s manufacturing processes and equipment to gain competency in order to provide technical support to production.
• Supporting the Quality Engineering Dept. performing investigations of product complaints.
• Supporting the CAPA Team by resolving the issues in a timely manner.
• Lead or participate in cross functional teams to introduce or improve processes resulting in components that exceed our customer expectations and deadlines and result in efficiency improvements and defect reduction.
• Utilize Lean Manufacturing and Six Sigma methodologies in project work.
• Monitor manufacturing activities, measure significant process characteristics and analyze variation in order to detect and reduce waste / scrap. Support the manufacturing process by taking corrective and preventative action on production delays and deviations.
• Analyze and recognize patterns and trends in key performance indicators.
• Transfer of automation and new process projects to production, both within and between sites.
• Transfer of new and existing products to production, both within and between sites.
• Work in cross functional teams on projects, including but not limited to, new process introductions.
• Assist in training employees in new or improved processes.
• Process and product validation (IQ, OQ, PQ).
• Develop and execute Process / layout design.
• Develop and support related process documentation for ongoing use within the existing system.
• Sourcing, specifying and purchasing production equipment, within budgetary guidelines.

Confidential, Miami, Florida

Process Engineer III - MEST / Extrusion Department

Responsibilities:

• Supporting the BWI Transfer project from California to Miami.
• Automated extrusion process to obtain over 92 percent of yield in production of catheter bodies with automated equipment.
• JJ Corp. is a leader in the development, manufacture and sale of disposable medical devices.
• Support the wire and air extrusion productions of JJ products.
• Supported engineering tasks for the AAA project.
• Participated in resolving engineering issues for the Compound area, Wire and Air Extrusion areas.
• Equipment consisted of robotics, electrical and mechanical controls, fluid devices, vision sensors, heated conveying, chemical application.
• Applied knowledge of engineering principles, research data, proposed specifications, computer modeling, and computer - aided design and drafting techniques in developing product, equipment, and system designs, meeting requirements of FDA, ISO, and GMP.
• Generated and released new drawings, and procedures for new process.

Confidential, Miami, Florida

Manager - Operations Dept

Responsibilities:

• Ensure that the business transactions were in order.
• Enforcing exporting compliances for timely completion of orders.
• Supervising that the orders were properly entered in the system and delivered.
• Ensuring that export logistics were expedited correctly and on - time.
• Coordinating customers and vendors activities.
• Supporting CPA activities.

Confidential, Fort Lauderdale, Florida

Sr. Automation Engineer - R&D Department

Responsibilities:

• Core R&D member for the Marlin project. Introduced new process to obtain almost 90 percent of automation and to fabricate strips (for glucose testing) with seven new - large automated equipment. The equipment had to be started, debugged, validated, and prepared for normal production.
• Automated equipment consisted of robotics, electrical and mechanical controls, fluid devices, vision sensors, pick and place cylinders, heated conveying, quemical application, labeling/marking equipment, and packaging the strips into plastic containers.
• Applied knowledge of engineering principles, research data, proposed specifications, computer modeling, and computer-aided design and drafting techniques in developing product, equipment, and system designs, meeting requirements of FDA, ISO, and GMP.
• Provided support the start up of new equipment / processes, designed to manufacture the new generation of strips for glucose testing.
• Generated and released new drawings, and procedures for new process.
• FMEA Team member as R&D and Manufacturing Sr. Engineer.
• Performed DOEs to optimize limits on new process.
• Generated protocols, reports, and executed IQ, OQ, PQ, and PPQ validations per the Master Plan.
• Supported troubleshooting of new automated equipment, while transferring the new equipment to Production / Manufacturing / Quality Process.

Confidential, Miami FL

Sr. Quality Engineer - Quality Dept.

Responsibilities:

• Sr. Manufacturing Engineer for the forceps and guide wires assembly lines.
• Supported the R&D requirements for new process and the corresponding drawings, specifications, and procedures. Ensuring that documents were in the controlled-configuration system (CPDM and SAP).
• Preparations of specifications, process study, research investigation (animal and clinical studies), and issued progress and final reports.
• Developed and/or conducted successful product testing used engineering principles and assigned to support the movement of the manufacturing operations from USA to Central America (Mexico and Costa Rica), performing re-validations with minimum production problems per the Master Plan.
• FMEA Team member as Sr. R&D and Manufacturing Engineer.
• Utilized Six Sigma and Lean tools in most projects, process, and problem solving.

Confidential, Miami, Florida

Team Leader - Cytometry Technical Support Dept.

Responsibilities:

• Core member for projects with new or improved process for the Cytometry Division.
• Team Leader for the Technical Support Group for the assembly lines to build Cytometry equipment.
• Worked with R & D Engineering, Technical Staff, and Manufacturing Manager in a deadline sensitive, fast - paced, performance-driven environment.
• Developed process for new projects, performed the validations, reported the results, and generated the corresponding documentation for final implementations.
• Analyzed data to determine feasibility of proposed projects.
• Plan, prepared, and coordinated the proper configuration management of documents (CPDM).
• FMEA Team member as R&D and Manufacturing Sr. Engineer.
• Executed IQ, OQ, PQ and PPQ for equipment, process, and product, per Master Plans.
• Evaluated materials and engineering technologies to apply new product development for medical products. Developed and implemented project plans with preparation of schedules and overseeing the implementation of projects per ISO regulations.
• Reviewed designs and calculations, using ANSYS (Finite Element Program).
• Troubleshot and resolved problems, developing design and/or testing modifications to assure reliability of finished products, equipment, and systems.

Confidential

Assistant Project Engineer

Responsibilities:

• Applied knowledge of engineering principles, research data, proposed specifications, computer modeling, and computer - aided design and drafting techniques in developing product, equipment, and system designs, including light-weight avionics, ground support equipment, airframe rack systems, sensors, and avionic digital and analog signal data recorders meeting requirements of MIL-STD-810, MIL-E-5400, MIL-E-4158, MIL-E-16400, AND MIL-T-28800.
• Reviewed designs and calculations, using ANSYS (Finite Element Program) and TNA (Thermal Network Analysis).
• Developed and/or conducted environmental and reliability testing procedures, performing diversified structural, stress, and thermal analyses of components and systems applying techniques including Finite Element Method (FEM) based computer packages.
• Assigned to support the movement of the manufacturing operation from one state to another with minimum production problems.
• Performed validations and/or revalidations of manufacturing operation process.
• Identified, developed, and implemented new process improvements.
• Supported the proper configuration management of drawings / documents.
• Applied knowledge of engineering principles, research data, proposed specifications, computer modeling, and computer - aided design and drafting techniques in developing product, equipment, and system designs, including light-weight avionics, ground support equipment and analog signal data recorders meeting requirements of MIL-STD-810, MIL-E-5400, MIL-E-16400, and MIL-T-28800
• Reviewed designs and calculations, using ANSYS (Finite Element Program) and TNA (Thermal Network Analysis).
• Member of the Configuration Management Team to ensure proper release of documents and drawings.
• Developed and/or conducted environmental and reliability testing procedures, performing diversified structural, stress and thermal analyses of electrical components and systems applying techniques and resolved problem, developing design and/or testing modifications to assure reliability of finished products, equipment, and systems.