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System Engineer

2 months ago

St Louis, United States Intellectt Inc Full time

Title: Systems Engineer

Location: St Louis, MO

Job Description:

  • Read, understand, and interpret applicable industry standards and government regulations.
  • Distill testable requirements from partial to complete designs and SME knowledge.
  • Perform risk analysis at component and system levels and generate relevant design mitigations.
  • Assist in test development for the system, surgical functions, and accessories.
  • Respond to integration & test issues with the best plans for rapid correction.
  • Adjust drafted requirements for subsystems of medical devices. Determine strategy and needs for life testing, and reliability testing necessary to hit design goals.
  • Use Aras PLM to create traceability between design inputs, design outputs, design documentation, regulatory standards, risk items, mitigations, and architecture.


Education & Qualification:

  • BS in Engineering (Systems, Biomedical, Electrical, Mechanical)
  • 7+ years’ experience as an engineer
  • Proven track record of launching complex electro-mechanical systems with a high regulatory burden.
  • Experience with risk analysis, requirement management, and verification planning. Excellent communication & organizational skills.


Skills:

  • Successfully launched a surgical medical device
  • Deep familiarity with the relevant regulations and industry standards (FDA, MDR, CA, UKCA, ISO, IEC, ETSI, etc...).
  • Experience using Aras PLM
  • Familiarity with medical device labeling