Senior Electrical Sustenance Engineer

Tasks

• Lead electrical engineering activities for sustaining and legacy medical device products.
• Investigate and resolve component obsolescence, supplier changes, and field issues.
• Perform root cause analysis and implement corrective and preventive actions (CAPA).
• Support design changes, verification, validation, and documentation updates.
• Ensure compliance with FDA, ISO 13485, and IEC 60601 standards.
• Collaborate with QA, Regulatory Affairs, Manufacturing, Test Engineering, and Supply Chain teams.
• Participate in risk assessments (FMEA), design reviews, and change control processes.
• Provide technical support to manufacturing, test engineering, and quality assurance teams.
• Maintain and update schematics, BOMs, test protocols, and technical reports.
• Ensure compliance with regulatory requirements and internal quality systems.

Requirements

• 6–8 Years
• Experience in medical devices, electrical circuit design, sustaining engineering, and regulatory compliance.
• Analog & Digital Circuit Design and Troubleshooting
• Schematics, PCB Design & Layout using Altium or OrCAD
• Medical Device Industry Experience (3+ Years)
• Medical Device Standards: IEC 60601, ISO 13485, FDA 21 CFR Part 820
• Component Engineering, Obsolescence Management & Alternate Sourcing
• Root Cause Analysis, FMEA, CAPA, 5 Whys & Fishbone Analysis
• Verification & Validation (V&V), Test Planning & Documentation
• Sensors, Drivers, Microcontrollers & Communication Interfaces
• Sustaining Engineering for Legacy Medical Device Products
• Embedded Systems and Hardware/Firmware Integration
• Technical Documentation: BOMs, ECOs, DHF and DMR
• PLM Tools: Agile and Windchill
• Any Visa | W2 Only

Schedule

• Contract
• hybrid

Location

• Cincinnati, OH