Responsibilities:

• Lead system-level design, development, and integration of the company system.
• Contribute to 510(k) submissions and write design and development documents.
• Perform system analysis, modeling, and simulation to optimize performance.
• Coordinate integration of hardware, software, and algorithmic components.
• Ensure compliance with regulatory requirements and industry standards.

Qualifications:

• Bachelor’s or Master’s degree in biomedical engineering or a related field
• At least 7 years of experience as an R&D engineer / System Engineer of a multi-disciplinary product.
• Strong understanding of medical imaging technologies and cardiac physiology.
• Familiarity with medical device regulatory standards (ISO 13485, IEC 62304).
• Experience in preparing 510(k) submissions and writing design and development documents.

Personal Skills:

• Strong communication and interpersonal skills.
• Flexible and effective in multidisciplinary team environments.
• Self-motivated with the ability to work independently.
• Detail-oriented with a commitment to quality and precision.
• Innovative thinker and good team player, passionate about cutting-edge medical technologies.