Primary Engineer responsible for the Fluid Management portfolio. Collaborating with Regulatory Affairs, Marketing, and Medical safety on FDA, customer and manufacturing enquiries.Support Design Development services with compliancy to Medical Device Registry (MDR).Managed CAD team residing in our Singapore location with the Design Transfer of the complete CAD inventory (CAD models, drawings and Bill of Materials (BOM)) of Negative Pressure Wound therapy (NPWT). BOMs uploaded and archived into Agile system for global use. CAD files successfully transferred into PDM for archival and revision control. Support the Urology and OR Accessories.

Conducted gap analysis on Design History Files for various Fluid Management products: Tubing, Canisters, and suction handles along with simpler products. Created and or revised various design control documentation: Design Input document, Trace Matrices, Compliance assessments along with supporting documentation. Wrote design verification protocols & reports to support user inputs by testing components within on-site lab. Wrote Stability studies with the aging of components under Ambient and Accelerated temperatures. Managed Lab technicians with conducting testing and verifying outputs and instruction with ISO standards ISO-10079-3, and 10079-4:2021

Utilizing SolidWorks, designed and documented CAD files for new pneumatic compression device for the treatment of Deep Vein Thrombosis (DVT).Managed CAD files into PDM.Supported global manufacturing sites with Engineering Change Orders (ECO).