Required Skills

Mechanical Engineer

Work Authorization

  • Us Citizen

  • Green Card

  • EAD (OPT/CPT/GC/H4)

  • H1B Work Permit

Preferred Employment

  • Corp-Corp

Employment Type

  • Consulting/Contract

education qualification

  • UG :- - Not Required

  • PG :- - Not Required

Other Information

  • No of position :- ( 1 )

  • Post :- 21st Dec 2020

JOB DETAIL

Support the Senior product safety architect tasks.

Regulatory registration support
--Provide engineering support to RA for global regulatory submissions related to the country target list including Brazil, USA, China, EU, Russia, India, etc. This involves helping convert existing program information into Registration required formats. Recommend how engineering can adjust processes to remove the conversion need in the future.
--Help support RA and engineering and coordinate country specific safety testing.
--Help support CT system California seismic planning and potentially execution.

CT Engineering Program support
--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 Client 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.
 

Company Information