IT Software Quality Engineer
Masimo
Bachelor’s degree is required in Software Engineering, Electronic Engineering or Biomedical Engineering. Advanced English. VISA B1 5+ years of experience in Quality, Regulatory, or Compliance roles within the medical device, diagnostics, or life sciences industry. Demonstrated success in regulatory authority interactions and external audits (FDA, ISO, EU MDR, or equivalent). Strong understanding of global regulatory frameworks (FDA QSR, ISO 13485, EU MDR, MDSAP). Experience with IEC 62304 (Medical Device Software – Software Life Cycle Processes). Knowledge of ISO 14971 (Risk Management) and applying hazard analysis to software. Familiarity with IEC 60601-1, IEC 62366, ISO 13485 depending on the device class. Proven ability to collaborate cross-functionally and communicate effectively with executive and external audiences. Excellent analytical, written, and verbal communication skills. Familiarity with cybersecurity principles for medical devices (encryption, secure boot, authentication).
Enero 21 2026 en Mexicali
