Date: November 30, 2023 | Posted by: HR Department
Responsibilities
Design and Development: Collaborate with the engineering team to design and develop medical devices, give inputs, and ensure compliance with regulatory standards and specifications.
Product Testing and Validation: Conduct testing and validation of medical devices, including performance testing, reliability testing, and safety testing, to ensure they meet quality standards.
Documentation and Reporting: Prepare and maintain documentation, including technical specifications, test protocols, validation reports, and regulatory submissions, as required by regulatory bodies and quality management systems.
Process Improvement: Identify areas for process improvement in device manufacturing, including optimizing manufacturing processes, enhancing product quality, and ensuring efficient production workflows.
Quality Assurance: Implement quality assurance procedures, such as conducting inspections, audits, and risk assessments, to ensure compliance with regulatory requirements and adherence to quality standards.
Regulatory Compliance: Stay updated with relevant regulations and standards in the medical device industry, ensuring compliance during the design, development, and manufacturing stages.
Collaboration and Communication: Work closely with cross-functional teams, including R&D, manufacturing, quality control, and regulatory affairs, to ensure effective communication and collaboration throughout the product lifecycle.
Troubleshooting and Problem-Solving: Analyze technical issues and troubleshoot problems related to medical device manufacturing, offering innovative solutions to improve device performance and reliability.
Qualifications
Education: A bachelor’s or master’s degree in Biomedical Engineering or Electronics with relative experience, Specialization in medical device design, manufacturing, or quality assurance is advantageous.
