Medical Manufacturing Engineer I — Temp (24M)

ICU Medical Inc; Tijuana; On-site; MXN 420,000 - 620,000; Full time

Job summary

ICU Medical Inc in Mexico (Tijuana) seeks a temporary QA/Manufacturing Engineer (24 months) to manage resources, ensure process quality, and drive continuous improvement across production lines.

You will analyze nonconformances, validate processes (IQ/OQ/PQ), write work instructions, balance lines, develop BOMs and fixtures, oversee audits, and ensure compliance with ISO 13485, FDA, and related systems while supporting product transfers.

Qualifications

• Bachelor's degree in engineering required.
• 1–2 years of experience in the medical manufacturing industry.
• Experience with root cause analysis and problem solving.
• Knowledge of Quality Systems (ISO 13485, FDA).
• Experience with validation (IQ/OQ/PQ).
• Statistical tools and capability analysis (DOE, normality).
• Documentation: work instructions and PFMEA changes.
• Basic electronics, pneumatics, electricity and PLCs.

Responsibilities

• Manage human and material resources in the department.
• Ensure production processes meet quality standards.
• Review and follow up on quality nonconformances.
• Implement engineering changes and deviations as required.
• Coordinate product rework activities.
• Design production fixtures and develop layouts.
• Determine product sterilization cycles and staffing needs.
• Create and maintain Bills of Materials (BOMs).
• Update and revise manufacturing procedures.
• Perform design verification and validation testing.
• Develop visual work instructions and production aids.
• Conduct time studies and line balancing analyses.
• Participate in the validation of new production lines.
• Comply with ISO 13485, FDA and related quality systems.
• Apply continuous improvement methodologies (Lean, Six Sigma).
• Support product transfers and audits; address findings and CAPA.
• Verify critical quality control points throughout manufacturing.
• Request equipment repairs as necessary.
• Maintain 5S and general area cleanliness.

Skills

Root cause analysis

Quality systems

Validation processes

Statistical tools

DOE

Line balancing

Advanced English

Pneumatics basics

Education

Bachelor's Degree in Engineering

Job description

ICU Medical Inc in Mexico (Tijuana) seeks a temporary QA/Manufacturing Engineer (24 months) to manage resources, ensure process quality, and drive continuous improvement across production lines.

You will analyze nonconformances, validate processes (IQ/OQ/PQ), write work instructions, balance lines, develop BOMs and fixtures, oversee audits, and ensure compliance with ISO 13485, FDA, and related systems while supporting product transfers.