Systems Engineer IRVINE CA Minimum Requirements: Bachelor’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or Mechanical Engineering 5+ years of experience in a systems engineering role Experience leading complex medical device development from concept to market Strong knowledge of regulatory requirements and quality standards in the medical device industry (FDA, ISO 13485, ISO 60601) Experience with requirement management tools (PTC, JAMA, or DOORS) Availability for up to 25% domestic and international travel