Prototype Engineer

As an Operations Officer - Prototyping, you will collaborate closely with the design and development teams to support the realization of innovative medical device prototypes. Your role will involve hands-on fabrication, coordination with external vendors, maintenance of internal prototyping equipment, and ensuring that prototypes are developed efficiently to meet specified technical and quality standards as per requirements. You will work with engineers and designers to understand prototype requirements and specifications. Fabricating and assembling prototypes using various manufacturing methods such as 3D printing, machining, and manual assembly will be part of your responsibilities. Operating, maintaining, and calibrating internal prototyping equipment like 3D printers, machines, and laser cutters will also be essential. In addition, you will be responsible for sourcing materials, tools, and components required for prototype fabrication. Coordinating with external vendors for specialized fabrication, machining, and procurement activities, managing prototype build schedules, and documenting prototype fabrication processes and testing results accurately are crucial tasks in this role. Your skills in mechanical fabrication, assembly, and troubleshooting will be essential, along with proficiency in operating prototyping and fabrication equipment. A basic understanding of mechanical and electrical systems related to medical devices, the ability to read and interpret engineering drawings and schematics, and vendor management and material sourcing skills are required. Moreover, you should have knowledge of design for manufacturability (DFM) and prototyping best practices, good documentation and reporting abilities, effective communication and teamwork skills, and the ability to work independently under minimal supervision. Awareness of medical device development regulatory and quality standards, particularly ISO 13485, would be advantageous. Ideally, you should hold a Diploma in Mechanical Engineering, Biomedical Engineering, Industrial Design, or a related technical field. Certification or technical training in fabrication, machining, or prototyping techniques would be a plus. With at least 4 years of hands-on experience in a prototyping, fabrication, or technician role, prior experience in the medical device industry or a regulated industry is highly desirable. Overall, your role as an Operations Officer - Prototyping will be pivotal in ensuring the successful development of high-quality medical device prototypes through effective collaboration, meticulous fabrication, and adherence to technical and quality standards.,