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Sr. Systems Engineer

ProKatchers LLC

Pleasanton · On-site Contract Senior $65 – $67/hr Today

About the role

Job Description

Requirements

  • 5+ years of systems engineering experience.
  • Significant experience in software requirements development, requirements decomposition/ traceability.
  • Experience as a Software Systems Engineer with Class III Medical devices/ Class III Implants.
  • Experience requirements management tool
  • Experience with FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 62304
  • DFMEAS
  • Bachelor's degree required

Must Have:

  • Class III Medical devices/ Class III Implants
  • Requirements decomposition/traceability
  • Systems Engineering

Skills

DFMEAEC 62304EU MDRFDA 21 CFR 820ISO 13485ISO 14971Systems Engineering

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