| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLEEMAIL AVAILABLEPROFESSIONAL SUMMARYI have over 10 years of experience in manufacturing, commissioning and process validation of equipment/instrument, including more than 4 years specifically in FDA-regulated medical devices and the healthcare industry.Extensive knowledge in Windchill-Product Life Cycle Management (PLM), SAP and Validation Life Cycle (VLC).Thorough experience in using Six Sigma tools, FMEA, TMV, Root Cause Analysis, and Statistical Process Control (SPC).Experience in creating and developing SOP's, Installation Qualifications (IQ), Operational Qualification (OQ), Performance Qualification (PQ), DFMEA, PFMEA, 21 CFR Part 11 Assessment and Validation Summary Reports (VSR).Thorough understanding and knowledge of ISO 9000, 9001 and/or ISO 13485 standards, 21 CFR part 11 (Electronic Records, Electronic Signatures), 21 CFR part 210, 211 and 280.Experience working with Minitab, LabVIEW, JMP and other statistical software/techniques including determining batch sizes based on variability, Design of Experiments (DOE).Experience with GD&T and CAD Software AutoCAD, Solid Works, CREO and MasterCAM.Strong experience in implementation of Change Management/Control and Corrective Action and Preventive Action (CAPA) procedures.Writing and reviewing Standard Operating procedures (SOPs) and User Manuals.Good communication skills both verbal and written.CERTIFICATIONLean Six Sigma green belt (CSSGB) Manufacturing Standards and Standardization CertificateExcel - Statistical Process Control Implementing Supply Chain ManagementWORK EXPERIENCEManufacturing Engineer II Monument, COClient-Jabil Healthcare Inc Jan 2021 Apr 2024Determined manufacturing, validation and commissioning requirement for new machines, new equipment, vendor engagement and equipment integration, and revalidation for change- controlled equipment.Created change request and Change notice to release process and inspection sheets in Windchill PLM system after updating for required operations to produce parts.Successfully managed the transfer of medical device products and processes from development to manufacturing, ensuring adherence to regulatory standards and project timelines.Utilized solid modeling software (e.g., SolidWorks, CREO and AutoCAD) to create detailed 3D models for product design and development, streamlining the design process and facilitating accurate prototyping.Strong proficiency in statistical process control (SPC) methods, encompassing Lean Six Sigma tools for problem-solving and root cause analysis.Operated gages to take measurements of sample parts and analyzed data using Minitab to create reports after reviewing the process capabilities.Led cross-functional teams to identify and implement process enhancements, resulting in improved product quality and compliance with industry standards.Performed Design of Experiments (DOE), data analysis, and process validations to enhance product reliability and accuracy, including Test Method Validation (TMV).Specialized in the service, repair, and management of electro-mechanical capital equipment, including the development and optimization of service and repair business models.Supported supplier qualification strategy and ensured supplier processes meet standards including approving supplier/vendor validations through Production Part Approval Process (PPAP).Assisted NPI (New Product Introduction) Team with Material Master Data, Process Sheet, Routers, Inspection Sheets and process Documentation work.Identified, assessed, and mitigated risks associated with product and process design, utilizing risk management methodologies to ensure safety and efficacy.Contributed to continuous improvement efforts by actively participating in quality management initiatives, conducting root cause analyses, and implementing corrective and preventive actions to drive process excellenceConducted performance inspections of machinery, equipment, and tools to verify efficiency, promptly initiating corrective actions to address deficiencies and ensure product quality.Developed manufacturing processes aligned with statistical process control (SPC) principles, contributing to improved quality and consistency.Demonstrated proficiency in Lean Manufacturing and Six Sigma methodologies, applying tools and DMAIC for continuous improvement initiatives.Extensive experience on using Minitab for Data Analysis, R&R Analysis after Test Execution.Oversaw the development of validation protocols in accordance with Critical Quality Parameters (CQP), Automation Systems Delivery SOPs, and cGMP standards.Manufacturing/Supply Chain EngineerCoders Data LLC/Client-Medical Device June 2020 Jan 2021Supported new equipment acquisition efforts, including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as necessary.Integrated inspection and testing requirements into production plans, ensuring compliance with quality assurance standards.Conducted performance inspections of machinery and tools, identifying and resolving inefficiencies to maintain high product quality.Maintain high levels of accuracy in documentation, inventory counts, and input across all manufacturing areas.Developed, maintained and reviewed Bill of Materials (BOMs), Gage R&R Analysis, Routers, and Manufacturing plans.Reviewed and drafted CAD, Geometric Dimensioning & Tolerancing (GD&T) using SolidWorks, Matlab and CREO drawings to add content or remove as per the production or ongoing project requirements.Provided engineering teams with guidance on design concepts and specifications, leveraging manufacturing techniques for optimal equipment utilization.Ensured compliance with industry regulations in manufacturing processes and procedures, contributing to operational integrity and safety.Developed and maintained assembly processes, bills of material, and production routings, ensuring accuracy and efficiency throughout the manufacturing process.Prepared master schedule identifying main activities, supervised manufacturing team to enhance production & responsible for material management & supply chain.Successfully transitioned new products to volume manufacturing through meticulous process development and stabilization efforts, meeting tight deadlines and budget constraints.Applied advanced process monitoring programs using multivariate data analysis methods and techniques, enabling proactive problem-solving and continuous improvement efforts.Participated in investigations and execute plans to resolve process issues, including nonconformances (NC), complaint investigations, audit observations, and corrective and preventive actions (CAPA).Manage Inventory cycle counts and Root Cause Analysis resources to ensure accurate inventory balances for both company, resource requirements for stakeholder consideration and customer owned assets.Project Engineer/Manager Mumbai, IndiaAlvitech Services Pvt Ltd Feb 2013 Mar 2018Provide technical expertise to identify and implement continuous improvements in manufacturing operations, including the development of processes, research into emerging technologies, and assessment of process quality, cost, capacity, and capability enhancements.Managed capital projects from conception to completion, achieving project goals within allocated resources.Provided mentorship, guidance, and support to junior engineers and technicians, cultivating a collaborative and knowledge-sharing environment within the engineering team, fostering professional development and growthImplemented Lean manufacturing concepts, resulting in improved product quality, enhanced labor efficiency, and increased throughput.Trained 20+ production staff in new manufacturing processes, enhancing team capabilities and productivity.Developed training modules on equipment operation and maintenance, reducing downtime and enhancing equipment efficiency.Expertise in Assembly and testing of pressure vessels, including Lean Six Sigma tools for problem-solving, and root cause analysis, Project planning, problem solving in Manufacturing and Fabrication process.Provide technical expertise and guidance to project teams, including engineers, technicians to ensure the proper installation and operation of HVAC, piping, plumbing and oil rigs systems.Developed cleaning cycle for parts washer, Tanks, heat exchangers, mixers, and manual equipment.Developed and optimized CNC machining programs for electronics components, reducing cycle time by 15% and minimizing material waste.Coordinate with vendors, and suppliers to procure materials and equipment necessary for project implementation.Conduct quality inspections and audits throughout the project lifecycle to ensure compliance with design specifications, codes, and standards.Troubleshoot technical issues and recommend solutions to optimize system performance and efficiency.Prepared and reviewed of Isometric drawings, Bill of materials, technical reports, Pre-fabrication of spools as well as support and structures, transportation of pre-fabricated spools & structures from workshop to site.Procured and designed cutting tools, gages and work holding fixturing, mechanical components and assemblies.Efficient in management the development and implementation of goals, objectives, policies, and procedures pertaining to the Quality Management System.Mechanical Engineer Mumbai, IndiaHerald Maritime Services June 2012 Jan 2013Assisted for operate and maintenance of all auxiliary machines and engineering equipments which includes Generators, Steering Equipment, pumps, Compressors, Ventilations Systems, Air conditioning and Refrigeration systems.Major Responsibility included daily maintenance reports and maintaining mechanical and marine systems, pumps, all bilge well & waste oils tanks and safety equipment.Ensured compliance with regulatory standards and guidelines, maintaining a safe working environment for all employees.Reviewed project plans and proposals and worked with management to develop project objectives.Led cross-functional teams in the successful launch of 3 new product lines, adhering to strict timelines and budgets.Prepared and reviewed Isometric drawings, Bill of materials and other Technical reports.Production Engineer Mumbai, IndiaDesha Engineers Pvt Ltd July 2009 Dec 2010Designed equipment such as Reactors, Autoclaves, Agitators, Distillation-Columns, Condensers, Evaporators, Reboilers, Receivers and Storage tanks using AutoCAD, MATLAB and Pro-E design softwares.Collaborated effectively with cross-functional teams including R&D, Procurement, and Logistics to resolve operational challenges.Fostered strong relationships with suppliers to ensure timely delivery of materials and components, minimizing production disruptions.Implemented lean manufacturing principles resulting in a 15% reduction in production cycle time.Optimized workflow processes, reducing waste by 20% and increasing throughput by 18%.Implemented Lean principles such as JIT, Kanban, eliminating 7 waste and Ergonomics. Expertise in Assembly and testing of pressure vessels, Manufacturing and Fabrication process, Project planning, problem solving etc.Assisted in the development of Quality control policies and procedures. Interacts with production staff to oversee, develop and maintain company standards and Quality control measures. Efficient in management the development and implementation of goals, objectives, policies, and procedures pertaining to the Quality Management System.Monitored production planning and cost estimation, Procurement of gauging and inspection fixtures on new and existing jobs, Database Operations, review of general arrangement and procurement of raw materials.EDUCATIONTexas A&M University-Kingsville M.S in Industrial Engineering Aug 2018 May 2020Dr. Babasaheb Ambedkar Tech University-India B.Tech in Mechanical Engineering July 2005 July 2009Marine Engineering and Research Institute-India P.G. Diploma in Mechanical and Marine Engineering Jan 2011 Dec 2011 |
