Mexicali, Baja California- Beneficios superiores a LFT
Correo de contacto
*****@masimo.com
Giro
Maquiladora (Export.)
Actividad principal
Ensamble de sensores para oximetros (productos médicos).
Número de empleados
4350
Sitio Web corporativo
Aviso de privacidad
Descripción y detalle de las actividades
- Lead software quality engineering activities across the full product lifecycle, ensuring compliance with ISO 13485, FDA QSRs, IEC 62304, ISO 14971, and relevant cybersecurity and data-protection requirements.
- Develop, review, and approve software quality documentation, including validation plans, protocols, reports, requirements traceability, verification/validation evidence, and risk-management documentation.
- Drive software-related risk management activities, including identification of hazards, evaluation of risk mitigations, and verification of risk-control effectiveness.
- Lead complex investigations using advanced root-cause analysis, data analytics, and statistical methods to identify systemic trends, prevent recurrence, and drive corrective and preventive actions (CAPA).
- Partner closely with global Software Engineering, Systems Engineering, Product Security, Regulatory, and Clinical teams to ensure alignment around software development, V&V expectations, and Quality System Requirements.
- Lead and support software verification and validation activities, including test-method development, test strategy definition, automation opportunities, and readiness assessments for release.
- Validate software tools, automated test platforms, and data systems in accordance with Masimo’s Quality System and regulatory requirements.
- Provide technical guidance and mentorship to engineers and technicians across the Quality organization, strengthening skills in software quality, documentation practices, and problem-solving.
- Support New Product Introduction activities, including review of software requirements, design documentation, architecture assessments, and verification of deliverables needed for successful product launch.
- Review software elements of Device History Records (DHRs) and ensure timely closure of required documentation in compliance with procedures.
Experiencia y requisitos
- 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).
Beneficios
Número de vacantes 1
Área Calidad
Contrato Permanente
Modalidad Presencial
Turno Diurno
Jornada Tiempo Completo
Horario
- Tiempo completo
Estudios Carrera con título profesional
Inglés Hablado: Avanzado, Escrito: Avanzado
Disponibilidad p. viajar Si