Jobs → Engineering → Electrical Sustenance Engineer

About the Role We are looking for an Electrical Sustenance Engineer with experience in medical devices, electrical circuit design, sustaining engineering, and regulatory compliance. Key Responsibilities • 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 • Identify opportunities for design improvements and continuous improvement Requirements • 6–8 years of experience in electrical circuit design and sustaining engineering • 3+ years of experience in the medical device industry • Strong understanding of medical device standards: IEC 60601, ISO 13485, FDA 21 CFR Part 820 • Experience with component engineering, obsolescence management, and alternate sourcing • Proficiency in root cause analysis, FMEA, CAPA, 5 Whys, and Fishbone Analysis • Experience with verification and validation (V&V), test planning, and documentation • Knowledge of sensors, drivers, microcontrollers, and communication interfaces • Experience with sustaining engineering for legacy medical device products • Experience with embedded systems and hardware/firmware integration • Technical documentation skills: BOMs, ECOs, DHF, and DMR • Proficiency with PLM tools: Agile and Windchill