Sr manufacturing process Engineer

Aptyx; Piedras Negras; On-site; MXN 700,000 - 1,100,000; Full time

Job summary

Aptyx is seeking a Senior Manufacturing Engineer in Mexico to act as the technical lead for advancing manufacturing projects from concept through initial development to sustained production.

You will train, coach, and mentor engineers, lead quality initiatives, and ensure compliance with ISO 13485, ISO 9001, and FDA requirements while driving continuous improvement and robust problem-solving across the team.

Qualifications

• 5+ years in a manufacturing leadership role, preferably in MEDICAL DEVICES.
• Hands-on experience is a plus.
• Working knowledge of ISO 13485 / ISO 9001 quality systems and customer-specific requirements.
• Demonstrated success implementing Lean Manufacturing and continuous improvement, including SMED.
• Strong problem-solving, organizational, and team leadership skills.
• Effective communicator with both shop-floor teams and executive management.
• Excellent verbal and written communication ENGLISH skills.

Responsibilities

• Support the transfer process manufacturing lines of medical devices, IQ, OQ, PQ execution, statistical techniques, risk evaluation.
• Oversee quality systems to maintain ISO 13485:2016, FDA 820 and ISO 9001:2015 compliance.
• Lead root cause analysis and corrective action for internal and customer quality concerns.
• Promote a culture of quality and accountability throughout the plant.

Skills

Leadership

Problem-solving

Communication

Mentoring

Education

Bachelor's degree in Engineering

Associates Degree in Manufacturing

Tools

ISO 13485

ISO 9001

FDA 820

Lean Manufacturing

SMED

Risk Management ISO 14971

Job description

wide experience in medical devices process and transfers. Knowledge in ISO 13485, Risk Management ISO 14971, US visa is required. The Senior Manufacturing Engineer is responsible for being the technical lead for the processing of manufacturing projects through concept, Initial development and sustained production. The role will act as a trainer, coach, and mentor to help grow and develop the other engineers.

Responsibilities

• Support the transfer process manufacturing lines of medical devices, IQ, OQ, PQ execution, statistical techniques, risk evaluation.
• Oversee quality systems to maintain ISO 13485:2016, FDA 820 and ISO 9001:2015 compliance.
• Lead root cause analysis and corrective action for internal and customer quality concerns.
• Promote a culture of quality and accountability throughout the plant.

Qualifications

• 5+ years in a manufacturing leadership role, preferably in MEDICAL DEVICES
• Hands-on experience is a plus
• Working knowledge of ISO 13485 / ISO 9001 quality systems and customer-specific requirements
• Demonstrated success implementing Lean Manufacturing and continuous improvement, including SMED
• Strong problem-solving, organizational, and team leadership skills
• Effective communicator with both shop-floor teams and executive management
• Bachelor's degree in engineering,/ Associates Degree in manufacturing, or a related field, or equivalent experience
• Excellent verbal and written communication ENGLISH skills