MES Engineer II (Onsite)

Overview:

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you.

We are the people behind the people who keep saving lives.

Responsibilities:

Independently or with minimal supervision, performs complex engineering tasks related to the MES system. This role requires sound judgment, initiative, and technical expertise to solve problems, propose improvements, and ensure operational efficiency.

• Must know and follow company policies and procedures related to work activities within their area of responsibility and ensure that subordinates are aware of and comply with company policies and procedures relevant to their work activities and areas of responsibility.
• Complete training in responsibility within the assigned timeframe. Training is required for changes and implementations of existing policies and procedures, new functions, etc. Complete any required retraining in areas such as safety and environmental compliance.
• Follow all company safety policies and precautions within the work area. Promote safety to all associates entering the work area.
• Responsible for leading and executing projects focused on reducing variation caused by process and/or MES (Manufacturing Execution System) design, positively impacting business metrics, strategic direction, and financial results.
• Lead technical projects at the manufacturing site and/or with suppliers to improve documentation processes, maintenance, and enhancements within the MES system.
• Provide technical support for the approval and validation of changes and improvements in processes within the manufacturing site and/or with the MES provider.
• Provide technical support for resolving quality issues related to documentation processes within MES.
• Potentially coordinate supervisory activities in MES technical areas.
• Maintain supply chain continuity in matters related to MES.
• For positions with supervisory responsibilities, ensure that subordinates follow all company guidelines related to health, safety, and environmental practices, and that all necessary resources are available and in good condition. Responsible for purchasing and designing equipment that meets safety and environmental requirements.

The MES Engineer Level II supports the implementation, maintenance, and continuous improvement of the MES system (Critical Manufacturing), ensuring proper execution of manufacturing processes, regulatory compliance, and system stability on the production floor, under the guidance of senior engineers or MES leaders.

• Support configuration, execution, and monitoring of manufacturing processes within the MES system.
• Participate in the implementation of new MES functionalities, workflows, and engineering changes (SCN/CCN), following established procedures.
• Provide second-level support to Manufacturing, Quality, and Engineering teams for MES-related incidents.
• Execute and document functional testing activities (FAT/SAT/UAT) for system changes and enhancements.
• Support computerized system validation (CSV) activities, including IQ/OQ/PQ protocols, under supervision.
• Assist in the creation and maintenance of technical documentation, work instructions, and user guides.
• Support training activities for end users and technical personnel.
• Participate in root cause analysis (RCA) and corrective/preventive actions related to MES issues.
• Ensure compliance with GMP and applicable regulatory requirements.
• Escalate risks, deviations, or issues to the Senior MES Engineer or MES Lead as needed.
• Executes assigned tasks with moderate supervision.
• Participates as a technical team member in MES projects.
• Does not hold direct responsibility for strategic architectural or global system design decisions.

Qualifications:

Required Qualifications

Requires Engineering Bachelors Degree and 3+ years of relevant experience.

Preferred Qualifications:

Efficient modeling of manufacturing workflows within the MES system.

Database management related to the MES system desirable.

Bilingual (English – Spanish) preferable

1. Technical Expertise : Deep knowledge of specific MES software (e.g., Critical Manufacturing).
2. System Administration : Strong skills in system monitoring, error analysis, configuration, and maintenance.
3. Analytical and Problem-Solving Skills : Ability to analyze requirements, assess risks, and resolve complex technical and operational issues.
4. Communication Skills : Excellent written and verbal communication skills to effectively interact with various stakeholders.
5. Project Management : Ability to plan, coordinate, and manage projects, ensuring timely and within-budget delivery.
6. Preferred Technical Competencies :

• Design and automation of process flows
• Transfer of flows between traceability systems
• Programming language proficiency
• Development and validation of test methods
• Process validation
• Design validation and verification
• Electrical, Electronic, and PLC

1. Knowledge of Company Products and Operations Processes (preferred)
2. Knowledge of the Company’s Quality System

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.