Electrical Sustaining Engineer

Role Description

Senior Electrical Sustenance Engineer responsible for supporting legacy medical device products through electrical design improvements, troubleshooting, component lifecycle management, verification/validation activities, and regulatory compliance.

Roles & Responsibilities

• Lead electrical engineering activities for sustaining and legacy medical device products.
• Investigate and resolve electrical component obsolescence, supplier changes, and field issues.
• Perform root cause analysis and implement corrective and preventive actions (CAPA).
• Support electrical design changes, verification/validation, and documentation updates.
• Ensure compliance with medical device standards including IEC 60601, ISO 13485, and FDA 21 CFR Part 820.
• Perform risk assessments, FMEA, design reviews, and change control activities.
• Provide technical support to manufacturing, test engineering, and quality teams.
• Maintain and update technical documentation including schematics, BOMs, test protocols, and reports.
• Collaborate with QA, Regulatory Affairs, Manufacturing, and Supply Chain teams.
• Support continuous improvement initiatives and product reliability enhancements.

Required Technical Skills

Electrical Engineering

• Analog and Digital Circuit Design
• Electrical Troubleshooting and Testing
• Schematics Design and PCB Layout
• Altium / OrCAD Tools
• DFM/DFT Knowledge
• Sensors, Drivers, Microcontrollers
• Wired and Wireless Communication Methods
• Embedded Systems and Hardware/Firmware Integration

Medical Device & Quality

• IEC 60601
• ISO 13485
• FDA 21 CFR Part 820
• Design Controls
• Verification & Validation (V&V)
• Risk Management (FMEA, 5 Whys, Fishbone)
• CAPA
• DHF / DMR Documentation
• ECO and Change Control Processes

Tools & Additional Skills

• PLM Tools (Agile, Windchill)
• BOM Management
• MATLAB / LabVIEW
• Electrical Test Documentation
• Lean/Six Sigma Knowledge Preferred

Professional Skills

• Strong communication and documentation skills.
• Ability to manage multiple priorities and work in a regulated environment.
• Strong problem-solving and decision-making abilities.
• Ability to collaborate effectively with cross-functional teams.

Experience Required

• 6–8 years of electrical engineering experience.
• Minimum 3 years of experience in medical device or regulated industry.
• Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, or related field. what should be the tittle