IT Software Quality Engineer

Masimo; Mexicali; Presencial; MXN 1,348,000 - 1,619,000; Jornada completa

Descripción de la vacante

A leading medical technology company in Mexicali, Baja California, is seeking a Lead Software Quality Engineer to oversee quality engineering activities throughout the product lifecycle. The role involves developing quality documentation, managing risks, and supporting new product introductions. Ideal candidates have a Bachelor’s degree and over 5 years of experience in Quality or Regulatory roles, along with a strong understanding of regulatory frameworks like ISO 13485 and FDA QSR. Excellent communication skills and technical guidance abilities are also essential.

Formación

• 5+ years of experience in Quality, Regulatory, or Compliance roles within the medical device industry.
• Demonstrated success in regulatory authority interactions and external audits.
• Strong understanding of global regulatory frameworks.

Responsabilidades

• Lead software quality engineering activities across the product lifecycle.
• Develop and approve software quality documentation.
• Drive software-related risk management activities.
• Lead complex investigations for systemic trends.

Conocimientos

Root-cause analysis

Regulatory compliance

Quality assurance

Data analytics

Technical documentation

Collaboration

Communication skills

Educación

Bachelor’s degree in Software Engineering, Electronic Engineering or Biomedical Engineering

Descripción del empleo

• 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.

• 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).