Engineering Manager, Medical Device Manufacturing

Foxconn Baja California; Tijuana; Presencial; MXN 900.000 - 1.500.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Descripción de la vacante

Foxconn Baja California seeks an experienced Engineering Manager to lead manufacturing and process engineering for regulated medical device production, focusing on catheter assembly and related products.

You will oversee validation, transfers, and scale-up activities, drive quality and capacity improvements, and collaborate with Quality, Operations, R&D, and Supply Chain to ensure compliance with ISO 13485 and FDA requirements. Strong English communication is required.

Formación

• Bachelor’s degree in Engineering or related technical field.
• 8+ years in medical device manufacturing.
• 5+ years leading engineering teams.
• Experience with catheter manufacturing or similar regulated products.
• Strong knowledge of process validation, risk management, and manufacturing transfers.
• Familiarity with ISO 13485, FDA quality requirements, and cleanroom operations.
• Lean Manufacturing and Six Sigma experience.
• Advanced English communication skills.

Responsabilidades

• Lead manufacturing, process, and industrial engineering teams in medical device production.
• Develop and implement manufacturing processes for catheter assembly and related products.
• Manage new product introduction, manufacturing transfers, and production scale-up activities.
• Oversee equipment qualification and process validation (IQ, OQ, and PQ).
• Drive improvements in productivity, yield, quality, and capacity.
• Support cleanroom manufacturing and compliance with quality system requirements.
• Collaborate with Quality, Operations, R&D, Supply Chain, and corporate engineering teams.
• Establish engineering metrics, resource plans, and technical development strategies.
• Lead root-cause investigations and corrective and preventive actions.
• Evaluate automation opportunities and capital equipment projects.

Conocimientos

Leadership

Engineering management

Process validation

Lean Six Sigma

Quality systems

Cross-functional collaboration

English communication

Educación

Bachelor’s degree in Engineering

Descripción del empleo

Foxconn Baja California seeks an experienced Engineering Manager to lead manufacturing and process engineering for regulated medical device production, focusing on catheter assembly and related products.

You will oversee validation, transfers, and scale-up activities, drive quality and capacity improvements, and collaborate with Quality, Operations, R&D, and Supply Chain to ensure compliance with ISO 13485 and FDA requirements. Strong English communication is required.