Hardware Engineer

Hardware - Electrical Engineer – Medical Device - Ablation Generator SystemsKey Responsibilities

• Design and develop analog and digital circuits for ablation generator systems, including:

Power electronics (SMPS, HV stages)

RF output stages

High-voltage isolation and protection circuits

Signal conditioning (voltage, current, impedance, temperature)

• Collaborate with mechanical, software, clinical, and regulatory teams to define system architecture and specifications.
• Conduct schematic capture, supervise PCB layout, and lead prototype development.
• Perform verification and validation (V&V) testing per ISO 60601 and other medical safety standards.
• Support electrical safety and EMC testing, including IEC 60601-1-2 compliance.
• Develop and maintain design documentation compliant with QMS and FDA/CE regulatory requirements.
• Troubleshoot and resolve technical issues throughout the product lifecycle.
• Contribute to risk analysis (e.g., FMEA) and design reviews.

• B.Sc. or M.Sc. in Electrical Engineering or related discipline.
• 5+ years of hardware design experience, preferably in Class II/III medical devices.
• Proven experience in ablation or electrosurgical generator design (RF, cryo, PFA).
• Strong expertise in high-voltage analog design, EMI mitigation, and isolation techniques.
• Proficiency with Altium Designer, SPICE simulators, and LabVIEW/Matlab.
• Familiarity with embedded systems, ADCs/DACs, and communication protocols (SPI, UART, CAN).

• Experience with IEC 60601, ISO 14971, and FDA Design Controls.
• Knowledge of thermal modeling and bioimpedance monitoring.
• Background in clinical applications of electrophysiology or cardiology devices.