Assist with Intertek IEC report updates related to the engineering programs that are introducing new CT products. Collect SDLC information from SW teams, Usability info from systems teams, markup reports, work with Intertek with questions, plan and coordinate test visits with GE safety lab.
Assist engineers in design planning for safety conformance during new product introduction / part change planning. General understanding of isolation diagrams, electrical principles of safety, mechanical principles of safety, high level EMC terminology.
Opportunity to learn the state of the art IEC safety standards and global structure of there use.
Assist with remaining Europe MDR compliance tasks related to supporting the RA technical file and risk management.
Assist in introducing the next version of standards into the existing design inputs flowdown structure.
Assist with planning for biocompatibility standards conformance.
Assist with a CT system research study\'s safety and regulatory and compliance for Europe.
Quality Controls / Procedures
Assist and work with QA and engineering to architect improved regulatory inputs flowdown and conformance management following ISO13485 principles.
Assist and work with QA and engineering to streamline product cleaning assessment planning and create local guidelines.
Assist and work with QA and engineering on streamlining accessories compliance and coexistence procedures and help create local guidelines.
General Out of scope items
General RoHS2, REACH, environmental compliance related.