VENKATESH GANESAN

R&D

Project 1: IPD DV Remediation

• Handling DV (Design Verification) Remediation activities for IPD (Infusion Preparation and Delivery Medical Devices) products at euMDR program.
• To create and manage the project time plan, ensure that tasks are completed according to the plan.
• Created detailed documentation related to design specifications, test protocols, and operational procedures.
• Preparation of Design History File (DHF). Conduct design review meetings to qualify the Device Product.
• Experience in Managing Risk Management requirement as per ISO 14971.

Project 2: PIVC Labeling Implementation

• Worked Project for PIVC Labeling implementation at euMDR Program.
• Handling Labeling graphic design, documentation like ISO compliance report, DV summary report, DV plan, Design Transfer Plan (DTP), Supplier Qualification Plan (SQP) for PIVC products.
• Support to identify the Gaps from Packaging cartons and labeling and create redlines against the euMDR Program.

Project 3: Sustenance Engineering (Project President– Luers Design updating as per ISO 80369-7)

• Worked Project for Sustenance engineering (Project President– Lures Design updating as per ISO 80369-7).
• To be find the Gaps Lure adaptors as per ISO 80369-7 2021, update the Lure current drawings, conduct the design review meetings and release the SAP.
• process validation including FAI/FAT, process development and IQ/OQ/PQ.

R&D - QA

• periodic supplier performance reviews and provide input/recommendation to evaluate supplier status.
• Contacting ROHS test for samples at regular interval.
• Handling rubber testing equipment UTM, Hardness tester and Viscometer.
• Handling measurement equipment Vernier caliper, Height gauge, Digital thickness gauges, VMS, Bore gauges.

R&D

• Conduct CFT meetings for feasibility review and APQP meetings for product developments
• Review, monitor, and control APQP to meet customer requirements
• Drive MSA, SPC, and calibration plan execution.
• Conduct CFT meetings to technically approve the tool layout.
• Produce the pilot lot and prepare the PPAP document according to customer requirements.
• Have knowledge of DFMEA, PFMEA, and Control Plan.
• Lead KPI meetings in the NPD department and take necessary actions to achieve targets.
• Implement ECN and ECR systematically for drawing changes.

R&D

• Design of marshaling boxes and mechanical analog instrument parts using Solid Works sheet metal and AutoCAD software.
• Have knowledge about DFMEA, PFMEA and Control plan.
• Drive KPI meeting in NPD department and take necessary action to achieve the target.

R&D

• Conduct CFT meetings for feasibility reviews and APQP meetings for product development.
• Review, monitor, and control APQP to meet customer requirements.
• Perform MSA, SPC, and calibration plan execution.
• Technically approve the tool layout.
• Produce the pilot lot and prepare the PPAP document as per customer requirements.
• Have knowledge of DFMEA, PFMEA, and Control Plan.
• Lead KPI meetings in the NPD department and take necessary actions to achieve targets.
• Implement ECN and ECR systematically for drawing changes.