Smit Gajera Email & Phone Number

United States

Bartlett, Illinois, United States

• Planned and coordinated engineering projects from initiation to production readiness, including work instructions, production planning, and packaging data sheets, achieving a 95% on-time project completion rate.• Evaluated Design for Manufacturability (DFM) of automotive injection-molded parts through analysis of engineering drawings, CAD data, and GD&T requirements.• Collaborated with the quality team to conduct gauge R&R studies, improving measurement system accuracy.• Led APQP… Show more • Planned and coordinated engineering projects from initiation to production readiness, including work instructions, production planning, and packaging data sheets, achieving a 95% on-time project completion rate.• Evaluated Design for Manufacturability (DFM) of automotive injection-molded parts through analysis of engineering drawings, CAD data, and GD&T requirements.• Collaborated with the quality team to conduct gauge R&R studies, improving measurement system accuracy.• Led APQP meetings with customers & suppliers, ensuring new mold designs met specifications and produced compliant parts.• Support continuous improvement by implementing lean manufacturing tools including 5S, 5 why, DMAIC.• Worked closely with customers to develop project plans and timelines to make sure delivery is on time.• Development and implementation of quality control processes, ensuring compliance with ISO 9001:2015 standards.• Assisted the quality and metrology teams with PPAP, PFMEA, control plans, process flow diagrams, ensuring comprehensive documentation before customer submission. Show less

Wheeling, Illinois, United States

• Argon Medical - Custom Product Solutions is a leader in the design and manufacturing of disposable medical devices used in interventional, diagnostic, and therapeutic procedures with a specific focus in cardiology, radiology, oncology, vascular, and other surgical areas.• Conducted detailed technical reviews of production process design and associated documentation.• Provided comprehensive engineering support throughout the development and manufacturing phases of new products, while… Show more • Argon Medical - Custom Product Solutions is a leader in the design and manufacturing of disposable medical devices used in interventional, diagnostic, and therapeutic procedures with a specific focus in cardiology, radiology, oncology, vascular, and other surgical areas.• Conducted detailed technical reviews of production process design and associated documentation.• Provided comprehensive engineering support throughout the development and manufacturing phases of new products, while assessing proposed designs for their manufacturability.• Proficiently generated 2D drawings or 3D models for both new and existing products or fixtures.• Actively supported process validation initiatives, encompassing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).• Expertly performed root cause analysis to identify and resolve product/process issues, implementing both short-term and long-term corrective actions aimed at enhancing product quality and reliability.• Demonstrated responsibility for writing comprehensive reports, business correspondence, and meticulously crafted procedure manuals (SOPs) in adherence to advanced English language standards.• Collaborated with cross-functional teams comprising Quality, Manufacturing, Design, and Marketing, fostering effective communication and synergy among departments.• Implemented and maintained quality systems, ensuring strict regulatory compliance with FDA and ISO 13485 standards to guarantee product excellence and safety.• Established comprehensive project plans, schedules, and budgets, diligently monitoring project progress and proactively identifying and addressing potential risks with mitigation plans.• Actively engaged in root cause analysis and problem-solving to identify process improvement opportunities, enhancing overall operational efficiency.• Collaborated with the process engineering team to design for manufacturing and validate manufacturing processes. Show less

Master'S Degree, Mechanical Engineering

Bachelor Of Technology - Btech, Mechanical Engineering, First Class With Distinction

Activities and Societies: I had the opportunity to go for industrial visits to various companies of my state such as Windsor Machines.