Pravin Zamkade

About Pravin Zamkade

Working as a Design Assurance/ Manufacturing Engineer, acquired the expertise of Med Device Manufacturing, Design Assurance and Quality of site to site Product Transfer, Process validation, Product/ Process verification, Compliance/ Quality/ Remediation for Class II and medical devices.• Completed 12 product transfer projects that encompass the transfer of the Manufacturing operations, End of Line operations, and the full-blown transfer of the medical devices namely Knee Stems, Trilogy Metal Cups, Multi-polar Shells, Tibia Trays, Hip Modular Heads.• In-depth understanding of Design History Files, Device Master Records, DFMEAs, PFMEAs, Master Validation Plans, IQ/OQ/PQ, product development, and drafting SOPs.• Extensive knowledge of ISO 9001/13485/14971, 21 CFR Part 11, 210, 211, 820, Risk Management (ISO 14971), 510(k), QSR and cGMP Quality systems and standards, BSI standards, GD & T, Bioburden recovery, and biocompatibility.• Over 2 years of experience with a Special Purpose Machine manufacturing company, led various Design and Development projects for the Cost-effective and Qualitative Design using AutoCAD and CATIA tools.• As a Quality Intern, I provided solutions to improve product quality, safety and supported the Reverse Engineering team for the Lead time and Cost reduction of parts.• Decision-making, strong negotiation skills, leadership capabilities, and solid verbal and written communication skills. • Self-starter, problem-solver, organized, team player, and dedicated to work, multi-task, and handling critical projects that support base business.CERTIFICATION: ASQ Six Sigma Green Belt (No.

Experience

1. Design Assurance Engineer Iii

   Teleflex

   Apr 2024 — Present · Chelmsford, MA, US

   Lead planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.Create and maintain risk files consisting of but not limited to Risk Management Plans, Hazard and Risk Analyses, Failure Mode and Effects Analyses and Risk Management Reports to assess the risks associated with a product.Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing. Provide support to Regulatory Affairs with creating submissions and responding to submission questions. Help the team with regulatory approvals and responses to regulatory questions. Perform root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.Use appropriate quality tools and statistical techniques to collect and summarize data, draw conclusions with confidence, determine sample sizes, apply data distributions.Identify relationships between variables, calculate reliability, design and analyze experiments, determine process and performance capability, and make statistically supported decisions.Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.Analyze post-market surveillance data periodically throughout a product’s lifecycle to feed back into it’s risk file in order to reflect it\'s current risk profile. Provide direction to design assurance engineering technicians supporting assigned projects. Review and improve Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.

Education

• Cleveland State University

  Master of Science (M.S.), Mechanical Engineering

• Dr.Babasaheb Ambedkar Technological University, Lonere - Raigad

  Bachelors of Technology (B.Tech.), Mechanical Engineering

Skills

• Manufacturing
• Microsoft Excel
• Powerpoint
• Catia
• Engineering Design
• Matlab
• Solidworks
• Product Design
• Mechanical Engineering
• Autocad
• Machining
• Automotive
• Stress Analysis
• Engineering
• Abaqus
• Ansys
• Team Management
• Microsoft Word
• Microsoft Office
• English