
Innovative Medical Device Design Specialist
4 days ago
We are seeking a skilled Hardware Design Engineer to join our team. As a key member of our design team, you will play a vital role in developing innovative medical device solutions.
Responsibilities:
- Design multi-layer PCBs for medical devices, ensuring optimal performance, reliability, and manufacturability.
- Create 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.
Qualifications:
- 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.
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