Gowtham Raaj Kalarani Mugundan

· Supervise NPWT Assemblers and coordinate with Production Manager

· Create safe and professional working environment

· Train new NPWT department employees on assembling activities and processes

· Create work instructions on processes.

· Verify Rework, Repair/Service pump records and all necessary traceability records

· staff of NPWT Department

· Monitor activities of Repair/Service department

· Inspect quality of incoming parts/components and coordinate with quality engineers

· Verify pump birth records, rework records and quality test of pumps built

· Coordinate with Customer Service Department on incoming orders

· Coordinate with Purchasing Department on parts/components forecast and other purchasing activities

· Coordinate with Warehouse manager and associates with pump parts and components storage and handling.

· Provide Technical management oversight for projects

· Create and manage BOMs (Bill of Materials), part numbers, and archive related technical documentation.

· Evaluate compliance of raw materials with specifications and design requirements

· Apply engineering concepts to develop hazard analysis and failure mode effect analysis for the final product/product subsystems.

· Ensure relevant IEC (International Electro Technical Commission) standard requirements are met in the product.

· Provide engineering support to resolve part, component, and product non-conformances raised during an external regulatory audit as per ISO (International Organization for Standardization), EN (European Standards), MDD (Medical Device Directives) and QSR (Quality System regulations) requirements by Creating investigation plans, performing and documenting investigations and root cause analysis.

· Participate in design review meetings.

· Develop, verify, and validate biomechanical and mechanical test methodologies to evaluate products and software that are both in development phase and currently on the pre-market phase.

· Create and update technical documents that make up the Design History File, test protocols and results as per internal SOPs (Standards of Procedures) and Design Control (IS0 13485) procedures.

· Provide cross-functional support for Quality, Marketing, and Regulatory departments

· Institute design changes based on customer feedback.

· Repair and service devices with new parts

· Perform quality inspection on the returned devices

· Performance testing, product inspection on software, hardware, and the compatibility of all accessories of the medical device.

· Issue NCMRs for production loss and failed incoming inspection

· Maintaining the effectiveness of quality control system and non-conforming materials control system.