Bharath Choudhary

Work within Sustenance Engineering Department in managing product transfers across sites/EMs.

Responsible for developing validation and verification strategies for the line transfer between sites and EMs.

Responsible for Equipment validations including IQ,OQ,PQ and line integration and to optimize the production rates.

Responsible for Closing CAPA investigation and rectifying and implementation of preventive measures.

Process improvements within the line to reduce defects across stations.

Incharge of getting prototypes with the changes proposed by Development Engineers to run a feasibility check for the proposed changes.

Perform Failure investigation while failure during Aggregate performance qualification tests.

Technical documentation assessment per Regulation (EU) 2017/745 requirements for various fertility products including Hysteroscopy Uterine Manipulators, IVF Pipet, Endometrium Biopsy kits and Balloon catheters that are generally used during women fertility health.

• Remediating the gaps identified on the technical documents and conduct V&V activities involving packaging & aging studies,functional test requirements for the assigned products.
• Protocol creation and report preparation for the validation testings as a part of remediation plan.
• Finalizing the Engineering specifications by performing DOEs and substantiate with appropriate literature survey
• Administering the client PLM activities which includes document approval routing and Follow-up for Approvals.
• Review models and drafted drawings from the CAD team
• Coordinate with CAD team for Design change requirements from engineering department.
• Identify the worst-case scenarios for Validation activities and justify the same using rationale.

• Reprocessing of medical devices including Electrosurgical Devices and supporting generators and Trocar from reputed brands.
• Tear down analysis of the above stated medical devices.
• Develop Fixture concepts to Disassemble, assemble and to test the devices for their functionality check without damaging the intended use.
• Review the designs for refinement.
• Detail design and manufacturing support to vendors in develop and manufacture the fixtures.
• Performance comparison of reprocessed and OEM devices by performing functional tests
• Develop PFMEAs for reprocessing line to get the parts first time right.
• Offshore support for production line implementation.
• Preparation of fixture assembly and operational manuals

• Design, Developed and validated new Product EASY CHANGE for John Deere, Quick locking and unlocking of filters without any tools
• Successfully completed a major functionality complaint for TATA Trucks fuel filter
• Proof of concept of Combination filters (Filter in Filter concept Proposed) packaging space optimization
• Testing of Development Products based on Design Intent
• Raw Data and report preparation
• Test Scheduling and resource Management
• Coordinating with Cross-functional teams for Report Review
• Handle customer complaints and production complaints from Plant
• Coordinate Customer witnessed final Product Validation and customer complaint Verification
• Support in Lab documentation for IATF Audits
• Design Fixtures for testing and evaluation of the manufactured fixtures
• Support Internal Auditor and Quality team to close all the Internal Audit Points with respect to lab
• Part of 8D team and CAPA for the EOL testing queries
• Preparation of DVPs and PVPs coordinating with customer requirements
• Brainstorming for New Test Rig identification and design
• Calibration of Test Rigs