Job Description

• Optimizing product design, related accessories, and packaging
• Establish manufacturing processes and perform design transfer
• Evaluate product design, production process, tooling, and assemblies of the product for manufacturing feasibility
• Develop all relevant manufacturing process validation plan and/or protocols
• Perform verification and validation activities according to test methods and protocol
• Ensure test requirements meet quality and regulatory standards for medical devices
• Evaluate and select appropriate materials and components to fulfil product design criteria
• Maintain records of design, risk management and testing activities as part of Design History File
• Manage and liaise with vendors and suppliers towards full-scale production
• Support with all other ad-hoc tasks

Requirements

• Bachelor’s degree in mechanical/biomedical engineering, or related technical degree
• Minimum of 2 years experiences in medical device development/manufacturing industry (i.e product development/production/manufacturing)
• Knowledge of manufacturing methods and process validation framework
• Competent in 2D/3D AutoCAD models, design, technical drawings and engineering concepts
• Experience in product design for medical devices is an advantage
• Knowledge on ISO 13485 quality standards and requirements for medical devices is an advantage
• Good communication and decision-making skills, able to work independently

• Attention to details and is highly analytical
• Keen to troubleshoot and is creative and innovative in problem solving
• Proactive and comfortable working independently and as a team