Product Engineer - Medical Device Manufacturing (Tijuana)

Descripción y detalle de las actividades

The Product Engineer will be responsible for supporting the manufacturing and continuous improvement of medical devices, ensuring product quality, efficiency, and compliance with regulatory standards. This role acts as a key liaison between design, quality, and production teams.

Key Responsibilities

• Support the transfer and launch of new medical device products into manufacturing.
• Lead product and process improvements to increase efficiency and reduce cost.
• Maintain product documentation, including drawings, BOMs, and specifications.
• Troubleshoot product and process issues on the production floor.
• Ensure compliance with ISO 13485, FDA QSR, and other applicable regulations.
• Coordinate Engineering Change Orders (ECOs) and product updates.
• Participate in validations (IQ, OQ, PQ) and risk assessments (FMEA).
• Work closely with Quality, R&D, and Manufacturing teams.

Qualifications

• Bachelor’s Degree in Mechanical, Industrial, Biomedical Engineering, or related field.
• 4 years of experience in a product engineering role, preferably in the medical device or regulated manufacturing industry.
• Knowledge of GMP, ISO 13485, and FDA regulations.
• Experience with SolidWorks or other CAD software.
• Strong problem-solving and communication skills.
• Proficient in English (written and spoken).
• Knowledge of Lean Manufacturing or Six Sigma tools is a plus.

Incentivos

• Beneficios de acuerdo a la LFT
• Seguro de vida
• Fondo de ahorro
• Seguro de gastos médicos
• Transporte
• Servicios médicos en planta
• Comedor

Detalles del puesto

• Número de vacantes: 1
• Área: Ingeniería
• Contrato: Permanente
• Modalidad: Híbrido
• Turno: Diurno
• Jornada: Tiempo Completo
• Horario: Tiempo completo
• Estudios: Carrera con título profesional
• Inglés: Hablado: Avanzado, Escrito: Avanzado
• Disponibilidad p. viajar: No