Rayan D'Silva Email & Phone Number

An engineering professional with 16 years industrial experience including 14 years in Life Science. Possess experience in Process Validation, Complaint Management, Quality, Design and production engineering along with good leadership skill to manage projects across different geographies.Responsibilities:Manage projects by planning, organizing, monitoring and timely closure. Perform Process Validation in accordance to current good manufacturing practice (cGMP) regulations (2l CFR parts 210 and 211).Create FAT's, Equipment Validation, Master Validation, Test Method Validation protocols, execute and generate reports in compliance with GxP regulations.Statistical analysis using Minitab performing Capability Analysis, DoE, Gauge R&R, ANOVA and T – Studies.Responsible for medical device Complaint Management. Perform investigation, execute MDR and vigilance reporting, assessments and complaint closure.Experience in Quality Assurance and Regulatory Affairs projects.Manage and drive CAPA.Risk Management per ISO - 14971.Gap assessment to determine compliance with standards.Design & development of Orthopaedic implants and Surgical instruments. Reverse Engineering of medical device manufacturing tooling.Advanced skills with Pro/E Wildfire to create new designs, prototypes, tooling and manufacturing specifications using 3D solid modeling and detailing techniques.Experience in Design & development of Hydraulic Gear pumps.Coordinated and supported production department on daily basis to ensure latest manufacturing specifications and work instructions were used for automotive spring manufacturing.

• 

  M S Ramaiah Institute Of Technology

  Mechanical Engineering