Manufacturing Engineer I (Temp)

ICU Medical; 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

• Manage the human and material resources assigned to the department.
• Ensure production processes comply with established quality standards.
• Review and follow up on quality nonconformances.
• Implement engineering changes and deviations as required.
• Coordinate product rework activities.
• Design production fixtures.
• Develop production area layouts.
• Determine product sterilization cycles.
• Define staffing requirements for each production line.
• Develop production process flow diagrams.
• Create and maintain Bills of Materials (BOMs).
• Update and revise manufacturing procedures.
• Perform product design verification and validation testing, as required.
• Develop visual work instructions and production aids.
• Conduct time studies and line balancing analyses.
• Participate in the validation of new production lines.
• Apply knowledge of quality standards, policies, and procedures, including ISO 13485 and FDA regulations.
• Utilize continuous improvement methodologies and tools.
• Implement quality improvements in production processes.
• Support and monitor product transfer activities.
• Manage and follow up on raw material rejections.
• Support internal and external quality audits.
• Analyze internal product rejections related to nonconformances.
• Generate process deviations when required.
• Follow up on audit findings and nonconformances.
• Verify critical quality control points throughout the manufacturing process.
• Request equipment repairs as necessary.
• Provide general supervision of the assigned area, ensuring cleanliness, discipline, and adherence to 5S principles.
• Understand and comply with policies and procedures related to the Quality Management System (ISO 13485), Environmental Management System (ISO 14001), Occupational Health and Safety Management System (OHSAS 18001), and any other management systems required for company operations.

• Bachelor's Degree in Engineering.
• 1-2 years of experience in the medical manufacturing industry.
• Experience applying root cause analysis and problem-solving techniques.
• Knowledge of Quality Systems (ISO 13485, FDA).
• Experience with validation processes (IQ, process parameter characterization, OQ, and PQ).
• Statistical tools (process capability, DOE, normality analysis, etc.).
• Document generation, including work instructions.
• Participation in or coordination of changes to pFMEA.
• Cleanroom regulations.
• Basic manufacturing knowledge.
• Continuous improvement tools (Lean Manufacturing, Six Sigma).
• Line balancing.
• Time studies.
• Statistics.
• Basic knowledge of electronics, pneumatics, electricity, and PLCs.
• Advanced English proficiency.

*Only candidates who meet all requirements will be considered for an interview.

*This position is temporary (24M)