- Ensure that production processes comply with established design requirements.
- Manage projects and activities with medium to high impact.
- Coordinate work teams for project management activities.
- Develop process flow diagrams and production process layouts.
- Update or correct manufacturing and product procedures, as required.
- Perform product design testing.
- Manage and participate in the validation of new production lines.
- Write and execute process validation protocols, equipment qualifications, material qualifications, and test methods, as well as ensure timely follow-up throughout the approval process.
- Participate in the development of master validation plans for various production lines.
- Maintain the validated state of equipment and production processes.
- Participate in the development and maintenance of pFMEA risk analyses.
- Replace obsolete equipment and fixtures with new equipment, including capital investment generation and analysis.
- Perform statistical capability analyses and use basic statistical tools.
- Understand and apply quality standards,



policies, and procedures, including ISO 13485 and FDA requirements.
- Manage and implement continuous improvement tools.
- Provide support and follow-up for products undergoing transfer.
- Participate in internal and external quality audits.
- Request equipment repairs when necessary.
- Provide general supervision of the assigned area, including housekeeping, discipline, and 5S.
- Know and apply the policies and procedures of the Quality Management Systems (ISO 9001), ISO 13485, Environmental Management System (ISO 14001), Occupational Health and Safety Management System (OHSAS 18001), and any other systems required by the company for its operations.
- Work on special projects as assigned.
- Bachelor’s degree in Engineering required.
- 3–5 years of experience in a similar position.
- Manufacturing experience in the medical device industry.
- Thorough understanding and broad application of technica

📌 Validation Engineer II (Tijuana)
🏢 Icu Medical
📍 Tijuana