Lavis Gonsalves

Design Intent remediation for medical device

• Responsibilities:
• Product Teardown
• Gathering Information of components & Preparing Bill of Materials (BOM)
• Preparing ideation for cost reduction
• Creating 3D concept design

Fixture design for Assembly, disassembly and testing for medical devices

• Obtained vendor input during projects requiring third-party suppliers, helping to support cohesive operations and development.
• Responsibilities:
• Fixture design for Assembly, Disassembly and testing
• Coordinated technical requirements, scheduling and solution development for engineering design and test issues.
• Creation of CAD Part Drawings, Assembly Drawings using Solidworks.
• Vendor co-ordination for development of fixtures
• Tested feasibility, design, operation and performance of equipment, components and systems.
• Creating Bench marking reports
• Creating Manual for Fixture Assembly and Dis-assembly procedure & Fixture Operating procedure

Supplier Remediation: Supplier Qualification Activities & Data standardization

• Responsibilities:
• Creating AIM (Audit Information Management)records for supplier
• Leveraging existing AIM records
• Followed up with external supplier to gather information.
• Creating Audit record (external Audit)
• Preparing Internal Assessment
• Preparing Risk Assessment.

• Executing labeling CO’s in PLM (Adpativ)
• CO analysis, routing for approvers, updates
• Follow up with approvers on task and other CO task
• Updating CO in other system for tracking
• Other Miscellaneous task within labeling project for data update.