Suraj Khedkar

About Suraj Khedkar

Mechanical Engineer with over 4 years of experience in product design, lifecycle management, and quality systems within the medical device industry. I have led multiple design change projects from concept through global factory implementation, ensuring compliance with ISO standards (ISO 13485, ISO 14971, IEC 60601, IEC 60812).My expertise spans end-to-end product lifecycle management (PDLM),Designing, DFMEA, and risk management. I have independently managed CAPA(Corrective action Preventive action), ECR/ECO, and supplier-initiated change processes, driving cross-functional collaboration between R&D, manufacturing, and global suppliers to resolve critical production issues.With a strong grounding in Quality Management Systems (QMS), I focus on delivering robust, compliant, and user-centered designs.

Experience

1. Mechanical Designer

   Philips

   Apr 2025 — Present · Pune, IN

   Mechanical SPoC for Product design changes. Independently handling CAPA (Corrective action Preventive action),LCM (Life cycle Management), MLD (Modify Launched Design). • Through understanding of Medical Device QMS(Quality Management System), Resolving SICRs (Supplier initiated change requests), Released multiple design change projects through ECR/ECO till handshake with factories globally. • Lead in DHR(Device History Record) remediation and ensuring FDA audit readiness. • Global Factories and supplier visits to handle critical issues in production.

Education

• Savitribai Phule Pune University

  Bachelor of Engineering - BE, Mechanical Engineering

  2015 — 2019

• vidhya pratishthans english medium school, Baramati

  HSC, CBSE

• vidhya pratishthans english medium school,Baramati

  SSC, CBSE

• Visvesvaraya National Institute of Technology

  Master of Technology - MTech, Heat & Power Engineering