CH Biomedical, Inc. was founded in 2008 by a team of scientific and technological experts with overseas experience with the goal to improve survival and quality of life for end-stage heart failure patients. The headquarters is located in Suzhou Industrial Park while the wholly owned subsidiary, CH Biomedical USA, Inc., is in LA, California. CH Biomedical focuses on research and development of the state-of-the-art ventricular assist device (VAD), bringing benefits to the wide patient population with end-stage heart failure.more
VAD is a mechatronics device used to provide support to the heart pumping blood and maintain human blood circulation. Its core component is a blood pump, which draws blood from the heart, increases the pressure, and then pumps it to aorta. After more than 50 years’ research in the United States and other developed countries, VAD technology has been approved by FDA as an alternative treatment for severe heart failure in replacement of permanent heart transplant. So far, nearly 100,000 cases of clinical use have shown that VAD can help patients with heart failure to significantly improve quality of life and longevity with a possibility of cardiac rehabilitation. The VAD industry has developed into an important segment of the cardiovascular medical device industry.more
We are a diverse and innovative team. We respect and value every employee. We believe that each employee's uniqueness in wisdom, perspective and talent will contribute to the team’s development by leaps and bounds.
• BS degree in Mechanical Engineering or related field
• 5+ years of professional experience in 3D CAD modeling
• 3+ years of professional experience in Class III medical device R&D
• Proficient in creating component/assembly drawings and BOM
• Experienced in geometric dimensioning & tolerancing
• Experienced in design documentation including URS, PRS, DRS, and V&V reports
• Familiar with manufacturing process, DFM and DTC
• Familiar with medical device regulations and standards: 21 CFR 820; ISO 14971, 13485, 60601; FDA Human Factors Guidance, etc.
• Strong interpersonal communication and technical writing skills
• Ability to work in a dynamic, multi-lingual environment
• Up to 25% travel
• Legally authorized to work in the U.S.
• BS in Computer Science or related field; Advanced degree preferred
• 3+ years of relevant work experience
• Expert in C/C++ programming languages for embedded systems; medical device or safety critical applications experience is a plus
• Experienced in Windows application programming
• Familiar with any 16-bit/32-bit Microcontroller architecture, board bring up and device driver experience. Has hands-on experience with embedded software debugging tools and software
• Fluent in software fundamentals including software design, algorithm development, testing performance and data analysis
• Has knowledge of common communication protocols used on embedded systems (UART, CAN, SPI, I2C, XPC, UDS)
• Experienced in high quality documents preparation, including system requirements, product specification, state diagrams, flow charts, etc.
• Knowledge of FDA regulatory requirements (e.g. IEC 62304, ISO14971) is a plus
• Ability to work in a dynamic multi-lingual environment
• Strong interpersonal, communication and technical writing skills