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 adecuado 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 improve

📌 Engineering Manager (Tijuana)
🏢 Foxconn Baja California
📍 Tijuana