Chandan Kumar R

During my two-year tenure at Advanced Bio Mechanics Pvt Ltd, I held a significant role as a Mechanical Engineer and was entrusted with a diverse set of responsibilities:
1. Application of Mechanical Engineering Principles: I applied my comprehensive knowledge of mechanical engineering principles, theories, and concepts to specialize in creating designs that seamlessly integrated with assembly and manufacturing processes, ultimately optimizing production efficiency.
2. Medical Product Development: My responsibilities extended to researching, planning, designing, testing, verifying, and validating Class II medical products and systems, specifically focusing on respiratory devices.
3. Technical Communication: I effectively communicated technical content and project updates to stakeholders using both oral and written methods. This included delivering presentations, preparing meeting minutes, conducting design and technical reviews, and facilitating other forms of communication.
4. Contribution to Respiratory Product Development: I actively contributed to the design, development, research, and support of new or modified respiratory products for medical applications within a regulated environment. Additionally, I played a crucial role in developing and validating test methods used to evaluate the performance of these designs.
5. Collaboration with Medical Professionals: I collaborated closely with external medical professionals and the internal technical team to determine device requirements, ensuring alignment with industry standards and regulations.
6. Verification and Validation: My involvement extended to specifying and completing verification/validation testing and analyses, meeting both regulatory and internal ABM respiratory care requirements.
7. Problem Solving and Documentation: I conducted in-depth analyses and provided recommendations to address product design test issues and resolve product performance problems resulting from product complaints, manufacturing issues, or quality concerns. All solutions and design modifications were meticulously documented in accordance with internal ABM respiratory care processes, industry standards, and regulatory requirements.
8. Failure/Root Cause Analysis: I conducted Failure/Root Cause Analyses to identify and resolve device issues, actively assessing existing development procedures and proposing enhancements as necessary.
9. Engineering Change Management: I acquired a strong understanding of engineering change management processes, ensuring the smooth implementation of changes and process improvements throughout the product lifecycle.
10. Document Control Procedures: I took on the responsibility of establishing and maintaining document control procedures for various processes, including Device Master Record (DMR), Device History Record (DHR), Bill of Materials (BOM), and Impact Assessment documentation.
11. Product Longevity and Reliability: I actively contributed to defining the expected product lifespan of devices through reliability calculations, emphasizing the importance of product durability and longevity.
12. Risk Assessment: I possessed basic knowledge of Failure Modes and Effects Analysis (FMEA) and conducted basic risk assessments as required.
13. Laboratory Testing: I gained valuable hands-on experience in conducting laboratory tests, including Hass and Halt tests, and consistently adhered to electrical safety standards as per IEC-60601.
14. EMI/EMC Compliance: I provided crucial support to the EMI/EMC team to ensure compliance with IEC-60601-1-2 standards.

During my internship, I actively engaged in and contributed to the following crucial tasks:

1. Comprehensive Understanding of Supply Chain Dynamics: I took the initiative to expand my knowledge of various aspects of supply chain operations, diving deep into the complexities that enable smooth product development and efficient delivery processes.
2. Effective Supplier Collaboration: I assumed the responsibility of coordinating with our suppliers, placing a strong emphasis on fostering effective communication and collaboration. This ensured that project objectives were consistently achieved within the defined timelines.
3. Proficiency in ISO 13485 Standard: I made a dedicated effort to gain expertise in the ISO 13485 standard, which serves as a cornerstone in the medical device industry. This involved mastering the rigorous quality management systems required to uphold compliance with industry regulations.