Engineering Manager

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

About the role

We are seeking an experienced Engineering Manager to lead manufacturing and process engineering activities within a regulated medical device operation. This position will oversee product transfers, process development, equipment implementation, validation, and continuous improvement initiatives supporting catheter manufacturing.

The ideal candidate combines technical expertise, strong leadership, and the ability to collaborate with cross-functional teams in a fast-paced manufacturing environment.

Key responsibilities

• Lead manufacturing, process, and industrial engineering teams supporting medical device production.
• Develop and implement manufacturing processes for catheter assembly and related medical products.
• Manage new product introduction, manufacturing transfers, and production scale-up activities.
• Oversee equipment qualification and process validation, including IQ, OQ, and PQ.
• Drive improvements in productivity, yield, quality, and manufacturing capacity.
• Support cleanroom manufacturing and compliance with applicable 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 implementation of corrective and preventive actions.
• Evaluate automation opportunities and support capital equipment projects.

Requirements

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