Job Title: Senior Electrical Engineer – Medical Devices
Location: Blue Ash, OH
Role Description:
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.
Essential Skills:
- Bachelor's or master's degree in Electrical Engineering or a related field.
- Minimum 6–8 years of experience in electrical engineering, with at least 3 years in the medical device or regulated industry.
- Strong knowledge of analog/digital circuit design, schematics, PCB layout, and troubleshooting.
- Hands-on experience working with sensors, drivers, microcontrollers, 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 and digital circuit design – Strong design and troubleshooting skills.
- Schematics and PCB design/layout – Proficiency in tools such as Altium and OrCAD; knowledge of DFM/DFT.
- Component engineering – Obsolescence management and alternate sourcing.
- Medical standards compliance – IEC 60601, ISO 13485, FDA 21 CFR Part 820.
- Failure analysis – Root cause analysis (FMEA, 5 Whys, Fishbone).
- Verification and validation – Test planning, execution, and documentation.
- Embedded systems (preferred) – Basic understanding of firmware/hardware integration.
- Documentation and PLM tools – BOMs, ECOs, DHF; tools such as Agile and 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.
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 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
- Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English.
- Ability to multitask, understand customer requirements, retrieve relevant information, and provide timely and satisfactory responses.
- Ability to effectively prioritize and manage multiple activities and responsibilities.
- Ability to understand and follow complex written procedures.
- Ability to function in a team environment and deliver on team objectives.
- Ability to make decisions and solve problems while exhibiting situational judgment.
Keywords to Search in Resumes
IEC 60601, ISO 13485, FDA 21 CFR Part 820, Circuit Design, PCB Layout, Embedded Systems, MATLAB/LabVIEW, Sensors, Drivers, Microcontroller, Electrical Testing, DHF/DMR, Risk Management (FMEA), CAPA, Sustaining Engineering, Design Control.
Skills:
- EIS: Medical Device & Regulations
- EIS: Embedded Software/Firmware Development
Experience Required: 6–8 years
