Assistant Development Manager
Malaysia
• Oversee engineering teams of 5 (ME, EE and SW) to deliver commitments aligned to achieve medical product priorities.• Leading and implementing projects, including participating in the design, prototype, testing till production build process.• Good understanding of ISO 13485, FDA 21 CFR part 820 and other relevant standards (for e.g., IEC 60601-1, etc…)• Support clinical trials in India on newly approved FDA products and conduct various animal labs in United States, China and Malaysia for product that is under development.• Manage all phase of design process for first generation endoscopy surgical systems, including drafting, dimensioning, tolerancing, prototyping and documenting results. Known for quality excellence and a “do-it-right-the-first-time” design standard.• Mechanical design lead for 4chip and 3chip CMOS camera system. Responsible for mechanical design and release of files (3D CAD, drawings, specifications, BOM, etc…) for prototype and production builds.• Prepare test protocols and reports to ensure the product met the FDA 510(k)’s requirements.• Lead project engineer for AirSurgN Insufflator. Oversee and liaise with both ME and EE team to achieve ultimate project goal and deadline for 510k submission. Ensure all documents that are required in DHF (design history file) are completed and released accordingly by phase. • Part of ME team in Robotic Arm System. Directly involved in designing the base of robotic arm where all the electrical systems (3D camera, light, insufflator, and electrocautery) are embedded.• Perform Finite Element Analysis (FEA) studies and coming up with alternative ways to reduce temperature in camerahead.
