Electrical Engineer

Key Responsibilities

• Lead and execute electrical design verification testing (DVT) activities for implantable and external medical devices. 
  
• Develop and document test protocols, test plans, and verification procedures in compliance with quality and regulatory standards. 
  
• Perform bench testing using standard electrical engineering laboratory equipment (oscilloscopes, multimeters, function generators, etc.). 
  
• Analyze and interpret test data; summarize findings and provide clear technical documentation.
  
• Coordinate and track test investigations, ensuring timely completion and documentation accuracy. 
  
• Lead or support failure analysis and root cause investigations for test nonconformances and component issues. 
  
• Work closely with R&D, Quality, Manufacturing, and Systems Engineering teams to resolve technical challenges and ensure design robustness. 
  
• Support yield improvement activities, identifying and implementing process or design enhancements. 
  
• Maintain strict adherence to design control and quality system requirements, ensuring full traceability and compliance with FDA, ISO 13485, and IEC standards.
  

Must-Have Qualifications

• Bachelor’s degree in Electrical Engineering or related discipline with professional experience in electrical engineering in medical device product development or a highly regulated industry. 
  
• Proven experience in the DVT phase of product development and transition to manufacturing. 
  
• Strong background in data analysis using Minitab, JMP, or Microsoft Excel. 
  
• Demonstrated ability to lead and close projects involving cross-functional collaboration. 
  
• Experience performing bench-level testing and troubleshooting using standard EE test instruments. 
  
• Excellent technical documentation, communication, and problem-solving skills. 
  
• Proven ability to manage multiple priorities while maintaining attention to detail and compliance.
  

Preferred Qualifications

• Experience with active implantable or Class III medical devices. 
  
• Knowledge of IEC 60601, ISO 14708, and FDA Design Control (21 CFR 820.30) standards. 
  
• Familiarity with SPICE simulation tools, PCB design and layout, or circuit debugging. 
  
• Experience with root cause analysis, FMEA, and CAPA methodologies. 
  
• Demonstrated success in yield improvement initiatives and process optimization.