Er. Deepan Shanmugam
Lead Engineer | Post Market Surveillance | Expertise in Medical Device Complaint Handling | ISO 14971 | ISO 13485 | USA FDA Submission | Root Cause Analysis | CAPA Actions | Complaint Investigation Reports | Trend Anl
- Role
- Lead Engineer at HCLTech
- Location
- Madurai, IN
- LinkedIn followers
- 500 followers
About Er. Deepan Shanmugam
Biomedical Engineer with over 5 years of expertise in Multispeciality hospital settings, specializing in the Maintenance, Calibration, and Repair of Medical Equipments. Adept at ensuring the safe and effective operation of critical systems, including imaging, monitoring, and therapeutic devices. Equipment Installation: I am responsible for the precise installation and calibration of medical equipment to ensure optimal performance and patient safety. This involves meticulously setting up a range of devices, from imaging systems to life-support machinery, and performing thorough testing to verify accuracy and compliance with regulatory standards. 🪛Preventative Maintenance and Calibration: I oversee the preventive maintenance and calibration of medical equipment to ensure its reliability and accuracy. I meticulously calibrate equipment to maintain precise performance and compliance with industry standards, minimizing the risk of malfunctions and ensuring patient safety. Troubleshooting and Repair: I am adept at troubleshooting and repair of medical equipment to ensure its continuous and reliable operation. When equipment malfunctions or exhibits performance issues, I systematically diagnose the problem by analyzing error codes, conducting hands-on inspections, and consulting technical documentation. My approach involves identifying the root cause of the issue and executing targeted repairs or component replacements with precision. By addressing problems efficiently and effectively, I minimize downtime and restore the functionality of critical devices, thereby supporting the hospital’s ability to deliver uninterrupted, high-quality patient care. Documentation: I meticulously document all aspects of medical equipment management to ensure comprehensive tracking and compliance. This includes maintaining detailed records of equipment installations, maintenance activities, calibrations, repairs, Pndt Certificate, Aerb Certificate, Nema Certificate, Field Of Correction and MV reports. I also document performance data, incident reports, and any modifications or upgrades made to the devices. 🥇Achievements and Goals: I am proud of several key achievements, including the successful implementation of a hospital-wide equipment management system that significantly improved operational efficiency and reduced downtime. My goal is to continue driving innovation, ensuring our hospital remains at the forefront of medical technology, and ultimately enhancing patient care through more efficient and effective use of medical devices.
Experience
Lead Engineer
Mar 2025 — Present
Investigate and processing the complaints in Trackwise ( GCS, Legacy, and Salesforce).• Investigations in to product complaint using FMEA,CHR, and DHR, determining root causes and correctiveactions (CAPA).• Writeups for investigation summary, and codings for the reported and identified failures.• Ensure Compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR.• Maintain full complaint record (investigation report, test data, CAPA evidence).• Discuss with RCC teams to assess reportability and all the complaints were resolved based on the priority.
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