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Medical Device Hardware Specialist
3 weeks ago
At our organization, we are dedicated to revolutionizing healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives.
Job Responsibilities:
- Design multi-layer PCBs for medical devices, ensuring optimal performance, reliability, and manufacturability.
- Develop and optimize schematics and PCB layouts using industry-standard design tools (e.g., Altium, Eagle, OrCAD).
- Integrate hardware components such as microcontrollers, sensors, power supplies, communication interfaces, and other embedded system components.
- Work closely with embedded engineers to define system requirements and ensure smooth hardware-software integration.
- Collaborate with manufacturing teams to ensure design-for-manufacturing (DFM) principles are applied and designs can be scaled for production.
- Interface with component suppliers to select optimal parts, ensuring cost-effectiveness and availability.
- Develop and test PCB prototypes to ensure performance aligns with product specifications.
- Perform hardware debugging and troubleshooting to resolve design issues and optimize system performance.
- Conduct failure analysis, root cause analysis, and component selection reviews to enhance hardware reliability.
- Ensure designs meet medical device safety and regulatory standards, including ISO 13485, IEC 60601, and other relevant guidelines.
- Maintain comprehensive design documentation, including schematics, layout files, Bill of Materials (BOM), and technical reports.
- Contribute to risk management, FMEA, and validation processes to ensure product safety and quality.
- Optimize hardware designs for power consumption, signal integrity, EMI/EMC performance, and thermal management.
- Stay updated with the latest advancements in PCB technologies, materials, and industry best practices.
- Participate in peer reviews and provide constructive feedback to enhance team-wide design quality.
Requirements:
- Bachelor's degree in Electrical Engineering, Electronics, or a related field.
- 4+ years of experience in PCB design, with exposure to medical device development being highly preferred.
- Proficiency in PCB design tools such as Altium Designer, Eagle, or OrCAD.
- Familiarity with high-speed digital, analog, and mixed-signal PCB designs.
- Knowledge of EMI/EMC, signal integrity, and thermal management in PCB design.
- Understanding of medical device regulatory standards, including FDA guidelines.
- Experience with hardware communication protocols like UART, SPI, I2C, or CAN.
- Excellent communication and teamwork skills, with a strong problem-solving attitude.