Chennai, Tamil Nadu, India
I am a Lead Engineer with over 8 years of experience in Medical Devices Regulatory Compliance and New Product Development. My expertise includes EU MDR 2017/745, DHF Remediation, Technical File preparation, Risk Management (ISO 14971), Handling the new project w.r.t Automobile and medical devices product and Technical documentation for IATF14961. Currently at HCL Technologies, I lead projects for Class I–III devices ensuring regulatory submissions and compliance for global markets. I have successfully collaborated with cross-functional teams across Europe, Canada, and Asia-Pacific regions.
Delivered EU MDR 2017/745 compliant documentation for Class I–III medical devices. • Led DHF remediation and MDD vs MDR gap assessments for global regulatory submissions. • Collaborated with global Regulatory Affairs teams to finalize country-wise registration lists. • Applied ISO 13485 & ISO 14971 for compliance and technical excellence. • Supported Risk Management and Post-Market Surveillance activities.
Managed industrialization of new products and enhanced existing manufacturing processes for automotive and healthcare components. • Applied Lean Manufacturing and Toyota Production System (TPS) methodologies for process optimization and quality improvement. • Designed and validated trimming tools, leak test setups, jigs, fixtures, and gauges to support product launches. • Coordinated with suppliers and internal teams to ensure timely delivery of prototypes and production tools. • Ensured compliance with ISO standards and customer-specific requirements during product and process validation. The company is certified to ISO 9001:2008, ISO/TS-16949:2009, EMS ISO-14001:2004 and BS OHSAS -18001:2007.
Led end-to-end industrialization of new die-casting products. Drove Lean initiatives: SMED, Kaizen, VSM, 5S, Poka-Yoke. Designed & validated jigs, fixtures, trimming tools, leak test setups. Performed feasibility studies, cost estimation & tooling validation. Executed APQP, PPAP, FMEA, MSA, SPC and process validation. Conducted supplier audits, RFQs, prototype coordination, and PPAP approvals. Supported manufacturing with process optimization, defect reduction & yield improvement. Applied RCA, CAPA, 5Why for problem-solving.
Doiter Group of Companies are professional organizations involved in the manufacture and exports of Aluminium, Cast Iron and Nodular Iron components. These companies are comprised of experienced professionals to provide its customers entire value of Supply Chain, Manufacturing, Sourcing and Logistics. • Developed and managed project timelines for new product launches in the automotive and engineering sectors. • Conducted feasibility reviews, supplier audits, and supported process development and validation activities. • Prepared work instructions, standard operating procedures (SOPs), and tool correction feedback reports. • Implemented Lean initiatives, improving productivity and ensuring process compliance with industry standards. • Supported cross-functional teams during customer audits and quality reviews.
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