Senior Electrical Engineer

Job Title: Senior Electrical Engineer – Medical Devices

Location: Blue Ash, OH(Onsite)

Duration: 12 Months

Experience: 6–8 Years

Education: Bachelor’s or master’s degree in electrical engineering, Biomedical Engineering, or a related field with a strong electrical systems background.

Job Summary:

We are looking for a Senior Electrical Sustaining Engineer with experience in medical devices or other regulated industries. The candidate will support legacy medical device products, resolve electrical component obsolescence and field issues, implement design improvements, and ensure compliance with medical device regulations and quality standards.

Must-Have Technical Skills:

• 6–8 years of experience in electrical engineering, including at least 3 years in medical devices or a regulated industry.
• Strong experience in analog and digital circuit design, schematics, PCB layout, and troubleshooting.
• Hands-on experience with sensors, drivers, microcontrollers, and wired/wireless communication technologies.
• Knowledge of medical device standards: IEC 60601, ISO 13485, and FDA 21 CFR Part 820.
• Experience in sustaining engineering, component obsolescence management, and alternate component sourcing.
• Strong knowledge of root cause analysis, FMEA, CAPA, and failure investigation.
• Experience with verification and validation (V&V), test planning, execution, and documentation.
• Proficiency in PCB design tools such as Altium or OrCAD.
• Experience with BOMs, Engineering Change Orders (ECOs), and design history documentation (DHF/DMR).

Roles and Responsibilities:

• Lead electrical engineering activities for sustaining and legacy medical device products.
• Investigate and resolve component obsolescence, supplier changes, and field-related issues.
• Perform root cause analysis and implement corrective and preventive actions (CAPA).
• Support design changes, verification and validation, and technical documentation updates.
• Ensure compliance with FDA, ISO 13485, and IEC 60601 requirements.
• Participate in risk assessments, FMEA, design reviews, and engineering change control.
• Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, and Supply Chain teams.
• Provide technical support for manufacturing, testing, and quality-related issues.
• Maintain and update schematics, bills of materials (BOMs), test protocols, and engineering reports.
• Identify opportunities for continuous improvement and product reliability enhancements.

Preferred Skills:

• Basic understanding of embedded systems and firmware/hardware integration.
• Familiarity with MATLAB or LabVIEW.
• Knowledge of PLM tools such as Agile or Windchill.
• Lean or Six Sigma knowledge.
• Experience with medical device design controls and regulatory documentation.