Chennai, Tamil Nadu, India
Product Development Engineer with 2.5 years of experience in the medical device domain at HCL Technologies. I worked in Sustenance Engineering, supporting legacy products, executing change management activities, refining design documentation, and ensuring compliance with global regulatory and quality standards. My experience spans DHF documentation, risk management updates, change control, complaint analysis, CAPA 5-Why investigations, technical writing, and cross-functional collaboration with R&D, QA/RA, and manufacturing teams. I have contributed to multiple high-impact engineering and remediation projects, improved documentation processes, and supported regulatory submissions through accurate, audit-ready deliverables. Known for strong ownership, attention to detail, and structured execution, I enjoy working in complex, regulated environments where precision and compliance are critical. I am now exploring opportunities where I can leverage my experience in medical devices, documentation, and regulatory processes to contribute to engineering excellence and compliance-driven development.
HCL Tech – Johnson & Johnson (DePuy Synthes) - Supported global sustenance engineering for orthopaedic trauma & CMF implants/instruments, ensuring product safety, compliance, and lifecycle continuity. - Managed product lifecycle activities: design updates, risk assessments, CER/CEP reviews, complaint analysis, and regulatory documentation. - Led DHF/DMR and Technical File remediation to meet EU MDR, including SEV, LoAS, and essential documentation updates. - Handled CRs/CNs in Windchill & Agile PLM for drawings, documents, PQP, DFP, CTQ and scope modifications; performed 2D drawing updates using Creo. - Analyzed sales & complaints data and updated DCRM, PRM, RMR per ISO 14971; supported DRA and CAPA activities for trend analysis and corrective actions. - Reviewed V&V reports, PMS (PMP/PMSR), and clinical evaluation (CEP/CER) documents. - Supported supplier change documentation (PVE plan, PVE report, cover sheet) and managed NC, obsolescence, BOM updates, and data mining tasks. - Conducted KT sessions based on Surgical Technique Guides & IFUs; updated traceability matrix for design–regulatory alignment. - Collaborated with cross-functional teams (Regulatory, QA, Manufacturing, Supplier Quality, Sterility, Medical Affairs, Packaging & Labelling) and recommended design improvements. - Worked under ISO 13485 & ISO 14971 across all product lifecycle tasks. Key Achievements: 💠Optimized complaints handling by conducting CAPA 5-Why analysis, reducing recurrence rate of complaints by 1% year-over-year. 💠Accelerated a legacy project timeline by 20% through effective change management and process enhancements. 💠Presented an automation idea for Windchill change management, saving 3,750 hours of effort and ~$25,000 in cost across operating companies. 💠Recognized as ERS Process Champion for 3 consecutive quarters in 2023 for quality deliverables and client satisfaction.