Senior Equipment Engineer – Medical Devices & Validation

Intuitive; Mexicali; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Intuitive is seeking a Senior Equipment Engineer to ensure the efficient and reliable operation of manufacturing equipment used in the production of medical devices. You will design, develop, and maintain equipment and processes to meet high-quality standards and regulatory requirements.

You will lead validation activities (IQ/OQ/PQ), troubleshoot issues, and collaborate with cross-functional teams to support new product introductions and continuous improvement initiatives.

Responsabilidades

• Design, develop, and implement equipment and processes for manufacturing medical devices.
• Lead and manage equipment validation activities, including IQ, OQ, and PQ protocols.
• Troubleshoot and resolve equipment-related issues to ensure minimal downtime and optimal performance.
• Collaborate with cross-functional teams to support new product introductions and process improvements.
• Develop and maintain detailed equipment documentation, including specifications, maintenance procedures, and calibration records.
• Ensure compliance with regulatory standards (e.g., FDA, ISO) and company quality policies.
• Provide technical guidance and mentorship to junior engineers and technicians.
• Conduct risk assessments and implement corrective and preventive actions (CAPA) for equipment-related issues.
• Manage equipment procurement, installation, and commissioning projects.
• Monitor and analyze equipment performance data to drive continuous improvement initiatives.

Descripción del empleo

Intuitive is seeking a Senior Equipment Engineer to ensure the efficient and reliable operation of manufacturing equipment used in the production of medical devices. You will design, develop, and maintain equipment and processes to meet high-quality standards and regulatory requirements.

You will lead validation activities (IQ/OQ/PQ), troubleshoot issues, and collaborate with cross-functional teams to support new product introductions and continuous improvement initiatives.