THANDAVA MOORTHY SUBRAMANI
Ravensburg
Summary
Medical Device Production | Quality Engineer | Regulatory Compliance | Process Improvement
• Expert in medical device production and regulatory compliance with 3 years of experience ensuring product quality and safety under ISO 13485:2016, IEC 60601-1, and medical standards.
• A strategic partner in advancing healthcare technology with a solid foundation in technical expertise, Quality Engineer, Quality Control, Quality Assurance, and Process control.
• Proven track record as an operational strategist, skilled at guiding organizations in the medical device industry to drive efficiency and quality while meeting strict regulatory standards.
Overview
3
3
years of professional experience
3
3
Certification
Work History
Production Engineer / Service Technician
SternMed GmbH
10.2023 - 10.2024
- Responsible for assembling and testing medical devices to ensure safety and compliance with regulatory standards
- Lead assembly and production of medical devices, ensuring adherence to quality and safety guidelines take decision on nonconforming products identified in production
- Conducted IEC 60601-1 safety tests and FLUKE device functionality tests for ICU ventilators, patient monitors, and infusion pumps
- Conduct thorough investigations using 5 Why's to identify the causes of component and product failures, including nonconforming items from production and customer complaints
- Manage the CAPA process in both production and service data reports to identify opportunities for CAPA
- Support manufacturers by continuous monitoring on semi-finished and finished products to detect non conformities and Coordinates do the investigations on cause of V&V failures
- Under goes review on documentation reports for all the devices and validation planning according to the SOP's protocols
- Implemented ISO 13485 quality control checklists, Quality control plans guaranteeing high product integrityand quality improvements in the production area and lead improvement plan
- Improved efficiency with Lean principles, achieving significant cost savings without compromising in quality
- Ensured compliance with Quality Systems (SOPs, MIs, QIs) and managed ERP systems for inventory traceability
Technical Support Engineer (Intern)
Prashan Medical Technologies
06.2022 - 01.2023
- Conducted R&D and provided technical support in critical care products and trained engineering students on device operation
- Performed R&D for ventilators and ECG machines, aligning with ISO standards
- Designed small-scale medical devices with strict regulatory adherence
Production Engineer in Manufacturing Unit
Medion Healthcare Pvt. Ltd.
04.2018 - 07.2019
- Overview on quality control and regulatory compliance in the production unit for medical devices
- Managed quality control processes and compliance with ISO 13485 and EU MDR regulations
- Inspected incoming goods for quality, collaborated with suppliers to resolve issues with non-conforming parts
- Conducted ISO 14971 risk assessments, ensuring the safety of products
Education
Master's degree - Biomedical Engineering
UNIVERSITA POLITECNICA DELLE MARCHE
Ancona02.2022
Bachelor of Technology - Biomedical Engineering
KARUNYA INSTITUTE OF TECHNOLOGY AND SCIENCE
Coimbatore07.2018
Skills
- Product Development
- EU Medical Device Regulations (MDD, MDR)
- Project Management Tools (Teamcenter, Agile)
- Change Management
- Risk Management (ISO 14971)
- CAPA & Root Cause Analysis (QA)
- Quality Management Systems (ISO 13485)
- Internal Audits and Inspection
- Product and Process Validations
- High Proficiency in MS Office software (Microsoft Excel, PowerPoint and Word)
- Lean Six Sigma Black Belt
- SOP Documentation
- ERP System Inventory Management
- Highly effective and articulate communication skills
- Self-starting
- Critical thinking
- Active listener
- Excellent Technical Writing Skills
- Ability to work cross functionally
- Outstanding work ethic and dedication
- Problem solving
Certification
- Quality Management System ISO 13485:2016, TUV SUD
- Risk Management System ISO 14971:2019, TUV SUD
- Lean Six Sigma Black Belt, Exemplar Global
Languages
Tamil
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)
German
Elementary (A2)
Hindi
Intermediate (B1)
Italian
Elementary (A2)
References
Available on Request
Timeline
Production Engineer / Service Technician
SternMed GmbH
10.2023 - 10.2024
Technical Support Engineer (Intern)
Prashan Medical Technologies
06.2022 - 01.2023
Production Engineer in Manufacturing Unit
Medion Healthcare Pvt. Ltd.
04.2018 - 07.2019
Master's degree - Biomedical Engineering
UNIVERSITA POLITECNICA DELLE MARCHE
Bachelor of Technology - Biomedical Engineering
KARUNYA INSTITUTE OF TECHNOLOGY AND SCIENCE
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