Lead System Engineer

• Manage and mentor a team of system engineers, providing technical guidance, feedback, and career development opportunities.
• Lead the system engineering activities throughout the product lifecycle, including requirements analysis, architecture design, system integration, verification, and documentation.
• Establish and enforce the system engineering processes, methods, and tools, following the best practices and industry standards.
• Ensure the compliance of our products with the relevant quality and safety standards, such as ISO 13485, IEC 60601, and FDA regulations.
• Troubleshoot and resolve any system issues, risks, or challenges that may arise during the development or operation of our products.
• Evaluate and implement new technologies, tools, and methodologies to improve system engineering efficiency and effectiveness.
• Stay updated on the latest developments and innovations in the field of system engineering and medical devices.
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Requirements:

• Excellent leadership, communication, and interpersonal skills
• Proven experience as a system engineering team leader, system architect, or a similar role in the medical device industry
• Familiarity with the quality and regulatory standards and frameworks for medical devices, such as ISO 13485, IEC 60601, FDA 21 CFR Part 820, etc.
• Experience with the design, development, and testing of complex medical devices, surgical or diagnostic devices
• Bachelor's degree in system engineering, biomedical engineering, electrical engineering, or a related field