Medical Device Electrical Hardware Engineer (Sustaining Engineering)- Blue Ash, OH Onsite

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 design changes, verification/validation, and documentation updates in compliance with FDA, ISO 13485, and IEC 60601 standards. Collaborate with cross-functional teams to ensure timely resolution of product issues and implementation of design improvements. Participate in risk assessments (FMEA), design reviews, and change control processes. Provide technical support for manufacturing, test engineering, and quality assurance teams. Maintain and update technical documentation including schematics, BOMs, test protocols, and reports. Ensure compliance with regulatory requirements and internal quality systems. Generic Managerial Skills, If any

Role Descriptions: Bachelor’s or master’s degree in electrical engineering or related field. Minimum 6 8 years of experience in electrical engineering, with at least 3 years in a medical device or regulated industry. Strong knowledge of analog/digital circuit design, Schematics, PCB layout, and troubleshooting. Hands on experience on working with Sensors, Drivers, Microcontroller and different communication methodologies (On Board, Wired, Wireless etc.) Experience with medical device standards (IEC 60601, ISO 13485, FDA QSR). Must Have Technical/Functional Skills Technical Skills Analog & Digital Circuit Design Strong design and troubleshooting skills. Schematics and PCB Design Layout Proficient in tools like Altium, OrCAD; knowledge of DFM/DFT. Component Engineering Obsolescence management, alternate sourcing. Medical Standards Compliance IEC 60601, ISO 13485, FDA 21 CFR Part 820. Failure Analysis Root cause analysis (FMEA, 5 Whys, Fishbone). Verification & Validation Test planning, execution, and documentation. Embedded Systems (Preferred) Basic understanding of firmware/hardware integration. Documentation & PLM Tools BOMs, ECOs, DHF; tools like Agile, Windchill. Functional Skills Sustaining Engineering Support for legacy products and design updates. Cross-Functional Collaboration Work with QA, RA, Manufacturing, and Supply Chain. Regulatory Knowledge Understanding of global compliance requirements. Project Management Multitasking, prioritization, and milestone tracking. Continuous Improvement Lean/Six Sigma knowledge preferred., Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language. Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Candidate must be able to effectively prioritize and manage multiple activities and responsibilities. Ability to understand and follow complex written procedures is required. Ability to function in a team environment and deliver on team objectives is required. Ability to make decisions and solve problems while exhibiting situational judgement. Desirable Skills: Keyword: Skills: ISO 13485~EIS : Medical Device & Regulations~EIS : Embedded Digital Hardware Design and Development Experience Required: 6-8