Title Biomedical Quality Engineer

As a Biomedical Engineer at our company, you will be responsible for performing comprehensive Functional and Performance Testing of ICU ventilators and other respiratory devices to ensure they meet quality and safety standards before delivery. Your role will involve troubleshooting and resolving any technical issues that arise during testing and assisting the R&D Team in testing the software. You will also be required to document the test findings and prepare reports. Your duties will include providing production support to ensure that production is not hindered by quality testing procedures. You will play a key role in maintaining company quality standards and assisting in maintaining the required quality management systems such as ISO 13485 and ICMED 13495 in accordance with regulatory requirements. Additionally, as part of your responsibilities, you will provide technical support to customers and end-users, assisting in troubleshooting and repairing medical devices. You will also contribute to the ongoing maintenance and calibration of devices. Furthermore, you will be responsible for preparing and maintaining all necessary documentation such as user manuals, design specifications, and test reports. Your contributions to regulatory submissions will be crucial in ensuring compliance with industry standards. The ideal candidate for this position should hold a degree in Biomedical Engineering (B.E./B.Tech), Diploma in Medical Devices, Biomedical, Instrumentation, MSc/BSc in Respiratory Therapy, Critical Care, Paramedics, or Medical Devices. Prior knowledge or experience with ICU ventilators and Respiratory Devices would be preferred. Strong technical aptitude and the ability to understand and explain complex medical equipment are essential. Additionally, candidates should possess strong organizational and multitasking abilities, as well as analytical and problem-solving skills. Sincerity, honesty, and hardworking nature are qualities that we value in our team members.,