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 medic

📌 Manufacturing Engineer I (Tijuana)
🏢 ICU Medical
📍 Tijuana