Goal-oriented Staff Engineer with experience in the Medical Device industry FDA regulations and Electrical component settings. Forward-thinking when reviewing project requirements to determine precise solutions. Composed professional when working under tight schedules and limited budgets to achieve innovative designs meeting and exceeding objectives.
Skills
Microsoft Office Organization
Time Management
Data Handling Commitment
Accounting , Project management
Budgets, Project plans
Continuous drive for improvement
Decision making, Supply Chain
Ethics , Eng. Team Player
Negotiation skills
Inventory Management, Workflow
Statistical analysis using minitab
Creative problem solving
Experience
05/2016 to 03/2020
Staff EngineerWeaver Consultants Group – Columbia, MO,
Manages the project management activities using CQV, PDCA, and LEAN methodology to monitoring and control all the activities needed for successful vertical startup and project implementation.
Collaborates with business management to identify short and long-term projects to be undertaken; performs feasibility needs analysis to determine project timelines; manages the analysis, project identification, design, budget, communication, and integration of project plans; approves business workflow and project design; assesses business needs, Project Manager capabilities, and available project budgets.
Monitoring and Managed capital expenditures (CAPEX /SUPEX).
Managed capital equipment through evaluation, selection, run-offs, and implementation (ERS, FAT, SAT, VAT).
Lead all the validation activities according to the FDA regulations for medical devices (MVP/IQ/OQ/PQ).
Work with available data and resources that require judgment in the selection of alternatives and decision making.
Provide training to the associate following the procedures of the organization, the introduction of new products, project plan, optimal resource management among others.
Addressed and resolved technical concerns to comply with internal standards and regulatory requirements.
Provided technical evaluations of engineering design documents sourced from third parties, advising the design team on potential implementation plans.
Monitoring and Control the manufacturing process and compliance with the metrics (Production load, Sales, Productivity, Service STFR / OTP).
Provide resources and continuous improvements to the manufacturing processes.
Correct and prevent assembly errors that impact productivity and service level.
Monitoring and continuous improvement of high impact metrics (Yield, Scrap, Efficiency, Productivity).
Determine line balancing aligned with product demands.
Determined areas in need of improvement and managed resolutions.
Read and interpreted work order specifications and information to plan, schedule, and carry out jobs effectively.
Created a training manual for all employees to use as a reference guide (MIL).
Design manufacturing systems (Layout).
Directed cross-functional teams focused on supplier integration with technological strategies in order to enhance global procurement and materials management efficiency.
06/2007 to 08/2010
Manufacturing SupervisorAlbany International Corporation – Rochester, NH,
(Molded Case Circuit Breakers (MCCB and Fuses)
Documented and submitted employee attendance and work hours.
From 85 to 65 Employees under direct supervision.
Monitor and maintain quality standards.
Comply with production standards based on performance and production capacity.
Supervise and monitor the personnel assigned, ensuring assistance, conflict management, disciplinary actions, acknowledgments, among others.
Directed safety meetings and checked team compliance with protective equipment and behavioral practices.
Provided employee coaching and employment decisions.
Noted equipment problems and requested maintenance support to minimize downtime.
Monitored manufacturing variances to achieve quality improvement while resolving product process and equipment problems.
Education and Training
Expected in 10/2012
M.D.: Quality and Productivity Management Instituto Tecnológico De Santo Domingo (INTEC) - Dominican Republic, GPA:
Expected in 08/2006
Bachelor of Science: Industrial Engineering University Action Pro-Education And Culture (APEC) - Dominican Republic, GPA:
Expected in 04/2011
: ISO 9000 And EMS South Western Consultants - Nashville, TN 37214, GPA:
ISO 9000 : 2008 Internal Auditor
EMS-1401 : 2004 Internal Auditor
Expected in 03/2017
: Supply Chain And Finance Accenture Academy - Https://www.accentureacademy.com, GPA:
Lean System Train-the-Trainer (Error Proofing, TPM, 5S, SMED, KANBAN)
Applying Lean across the Enterprise.
Electrical Safety lockout tag-out (LOTO)
Institute Measurement System Analysis (MSA)
Structured Team Problem Solving (8D)
The supervisor and the 7-indispensable skills
The hallmarks of supervisory success
Coaching Bringing Out the Best in Others.
Building Team Pride and Purpose
Accomplishment
An active member of the team in the transfers of manufacturing lines (Plant to Plant) Arecibo (PR) / Haina (DR) 2008 - 2010 - Eaton
Lead projects and validation efforts of new product Introduction that resulted in the installation of 09 production lines of medical devices components, complying with all standards and regulations (FDA, MOC, QA, OEE, budget), providing nearly 600 new job positions. 2016-2019 Ecolab Microtek
Recognition for the levels of adaptability, effective communication, and delivery of projects in terms of cost and time for the manufacture of products, collaborating to increase sales and the company profits. Ecolab Microtek
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School Attended
Instituto Tecnológico De Santo Domingo (INTEC)
University Action Pro-Education And Culture (APEC)
