Manufacturing Engineer I

ICU Medical; Tijuana; Presencial; MXN 180.000 - 360.000; Jornada completa

Descripción de la vacante

ICU Medical is hiring a Quality Engineer to support manufacturing operations in Tijuana. The role emphasizes ISO 13485 and FDA compliance, root cause analysis, and driving improvement across lines.

You’ll participate in validations (IQ/OQ/PQ), create work instructions, balance lines, perform time studies, and help update BOMs while ensuring 5S and cleanroom standards.

Formación

• Bachelor’s degree in engineering.
• 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 processes (IQ, OQ, PQ).
• Statistical tools (process capability, DOE, normality analysis).
• Document generation including work instructions.
• Participation in or coordination of pFMEA changes.
• Cleanroom regulations.
• Continuous improvement tools (Lean, Six Sigma).
• Line balancing, time studies, statistics.
• Basic knowledge of electronics, pneumatics, electricity, PLCs.
• Advanced English proficiency.

Responsabilidades

• Manage resources assigned to the department.
• Ensure production processes meet quality standards.
• Review and follow up on quality nonconformances.
• Implement engineering changes and deviations.
• Coordinate product rework activities.
• Design production fixtures.
• Develop production area layouts.
• Determine product sterilization cycles.
• Define staffing requirements for each 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.
• Develop visual work instructions and production aids.
• Conduct time studies and line balancing analyses.
• Participate in validation of new production lines.
• Apply knowledge of quality standards and procedures (ISO 13485, FDA).
• Utilize continuous improvement methodologies and tools.
• Implement quality improvements in production processes.
• Support and monitor product transfer activities.
• Manage 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 manufacturing.
• Request equipment repairs as necessary.
• Provide supervision of the assigned area, ensuring cleanliness and 5S.
• Comply with QMS, EMS, and OHS management systems.

Conocimientos

Root cause analysis

Problem solving

Quality systems

Validation IQ/OQ/PQ

DOE / statistics

Lean / Six Sigma

Line balancing

Time studies

5S / cleanroom

Electronics / pneumatics / PLCs

Advanced English

Educación

Bachelor’s Degree in Engineering

Descripción del empleo

Responsibilities

• 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.

Qualifications

• 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 (20M).