Employer Active
Job Alert
You will be updated with latest job alerts via emailJob Alert
You will be updated with latest job alerts via emailNot Disclosed
Salary Not Disclosed
1 Vacancy
Role Electrical engineer
Location : Cincinnati OH USA onsite
An electrical engineer with IEC 60601-1 experience is responsible for ensuring the safety and compliance of medical electrical equipment with this international standard. This involves developing and implementing test plans conducting evaluations and creating documentation to demonstrate compliance
IEC 60601-1 Compliance:
Ensuring medical electrical equipment meets the requirements of IEC 60601-1 including related standards like IEC for electromagnetic compatibility.
Test Planning and Execution:
Creating and executing test plans collecting data analyzing results and writing engineering reports.
Documentation:
Preparing and maintaining technical documentation including test plans test reports and other relevant documents required for compliance and product lifecycle management.
Design Input:
Providing input during the design phase of medical devices to ensure compliance with IEC 60601-1.
Risk Management:
Contributing to risk assessments and hazard analysis related to electrical safety.
Troubleshooting:
Identifying and resolving technical issues related to electrical safety and performance.
Collaboration:
Working with cross-functional teams including other engineers product managers and regulatory specialists.
Testing:
Conducting various tests including dielectric strength leakage current and other safety-related tests.
Evaluation and Analysis:
Evaluating systems and components conducting feasibility studies and analyzing test results.
Equipment schematics general review for all the wires and connection details are identified as per NFPA/Local standards.
Development and qualification of electromechanical components such as Switch assemblies cable assembliesPCBAs.
Design review DFMEA DFM & Board Revision
Low-level Embedded drivers development for on-board peripherals & Motor control
Schematics & BOM updates for PCBAs
Write Module test plan and execution
Writing Engineering Studies for board level & device level testing
Design Transfer
Test Engineering scope:
Writing Test Specs for ICT/ FCT
Liaison technical discussions between supplier & design team and resolve stumbling blocks
Design review of Hardware & fixture for Functional Testers
ICT/ FCT Qualification and deployment of plant
Full-time