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
Beneficios superiores a LFT
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