· IEC 60601-1 Compliance:
Ensuring medical electrical equipment meets the requirements of IEC 60601-1, including related standards like IEC 60601-1-2 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 assemblies, PCBAs.
·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