Electrical Engineer – Sustaining; Medical Devices

Position: Electrical Engineer – Sustaining (Medical Devices)

Job Title:

Electrical Engineer – Sustaining (Medical Devices)

Key Responsibilities

• Provide electrical engineering support for sustaining and post-market activities of medical devices
• Investigate and resolve field issues, nonconformances, and design-related failures
• Support design changes, component obsolescence, and cost-reduction initiatives
• Perform root cause analysis, risk assessments, and corrective/preventive actions (CAPA)
• Support verification and validation testing for design updates
• Ensure compliance with applicable regulatory and quality standards (FDA, ISO, IEC)
• Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory, and Suppliers
• Maintain technical documentation, drawings, and design history files

Required

Skills & Qualifications

• Bachelor’s degree in electrical or Electronics Engineering (or equivalent)
• Strong experience in electrical design, sustaining engineering, or product support
• Hands-on experience with analog/digital circuits, power electronics, or embedded systems
• Experience working in regulated industries (medical devices preferred)
• Knowledge of design controls, risk management, and change management processes
• Strong troubleshooting, documentation, and communication skills

Preferred Qualifications

• Experience with medical device standards (IEC 60601, ISO 14971, ISO 13485)
• Exposure to failure analysis, reliability testing, and supplier engineering
• Experience supporting products through full lifecycle and post-market phases