Electrical Engineer - IEC 60601-1 Compliance Job at Yochana, Cincinnati, OH

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  • Yochana
  • Cincinnati, OH

Job Description

We are looking for an experienced Electrical Engineer with hands-on expertise in IEC 60601-1 standards to join our team. This role is crucial in ensuring the safety, compliance, and reliability of medical electrical equipment throughout the product lifecycle.

🔹 Key Responsibilities

  • Ensure compliance with IEC 60601-1 and related standards (IEC 60601-1-2, NFPA, etc.).
  • Develop and execute test plans , collect data, analyze results, and prepare detailed engineering reports .
  • Prepare and maintain technical documentation : test plans, reports, compliance files, and lifecycle records.
  • Provide design input during the product development phase to ensure compliance with medical device standards.
  • Conduct risk assessments and hazard analyses for electrical safety.
  • Perform electrical safety testing (dielectric strength, leakage current, functional testing, etc.).
  • Review equipment schematics, wiring, and connections as per standards.
  • Lead the development and qualification of electromechanical components (switch assemblies, cable assemblies, PCBAs).
  • Contribute to DFMEA, DFM, board revisions, and design reviews .
  • Develop embedded drivers for peripherals & motor control.
  • Create and update schematics, BOMs, and test modules .
  • Write and execute module test plans and engineering studies at board and device levels.
  • Support design transfer activities.
  • Define and implement Test Engineering scope : ICT/FCT test specs, hardware & fixture design reviews, and plant-level deployment.
  • Liaise with suppliers and design teams to resolve technical roadblocks.

🔹 Qualifications & Skills

  • Bachelor’s/Master’s in Electrical/Electronics Engineering (or related field).
  • Strong knowledge of IEC 60601-1 compliance & medical electrical equipment standards.
  • Experience with test engineering, PCB design, embedded drivers, and electromechanical components .
  • Solid understanding of risk management (DFMEA/DFM) and regulatory compliance processes.
  • Hands-on expertise with ICT/FCT testing and plant deployment .
  • Strong collaboration skills to work with cross-functional teams.

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