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A Day in the Life

We are seeking a Manufacturing Engineer I to join our Calibration team at our manufacturing site in Ciudad Juárez, Mexico.

This role will provide engineering support for calibration, equipment qualification, validation, and manufacturing activities in a regulated production environment. The ideal candidate will have hands-on experience with equipment and/or process validation, including IQ, OQ, and PQ, and will work closely with Manufacturing, Quality, Operations, and other engineering functions to ensure equipment and processes remain compliant, capable, and reliable.

The position is 100% onsite and requires regular interaction with manufacturing operations and production equipment.

Key Responsibilities

• Support calibration activities for manufacturing, inspection, measurement, and test equipment.
• Support the development, execution, and documentation of equipment qualification and validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support Test Method Validation (TMV) activities when applicable.
• Develop, review, and maintain engineering documentation, protocols, reports, specifications, and manufacturing procedures.
• Partner with Manufacturing, Quality, Operations, and technical teams to maintain validated equipment and processes.
• Investigate equipment, calibration, process, and product issues using structured root cause analysis and problem-solving methodologies.
• Support corrective and preventive actions related to equipment or process performance.
• Participate in risk assessments, including Process FMEA and other manufacturing risk-management activities.
• Analyze manufacturing and equipment performance using statistical techniques and recommend improvements.
• Support equipment changes, engineering changes, new equipment introduction, and manufacturing process improvements.
• Ensure calibration and validation documentation is completed accurately and in accordance with applicable quality-system requirements.
• Provide technical support directly on the manufacturing floor and help resolve issues impacting production, quality, or equipment performance.
• Support continuous improvement initiatives focused on equipment reliability, process capability, compliance, and manufacturing efficiency.

Minimum Requirements

• Bachelor’s degree in Engineering or a related technical/scientific discipline.
• Previous experience or demonstrated knowledge in a manufacturing engineering, validation, quality engineering, or calibration environment.
• Hands-on knowledge of equipment and/or process validation, particularly IQ, OQ, and PQ.
• Understanding of manufacturing equipment, measurement systems, and engineering documentation.
• Strong analytical and problem-solving skills.
• Ability to work effectively in a cross-functional manufacturing environment.
• Good written and verbal communication skills.
• English proficiency sufficient to work with technical documentation and global engineering teams.
• Ability to work onsite in Ciudad Juárez, Chihuahua, Mexico.

Preferred Qualifications

• Experience in medical device manufacturing or another highly regulated manufacturing environment.
• Knowledge of ISO 13485 and regulated medical-device manufacturing requirements. These are also identified as preferred capabilities in the internal Manufacturing Engineer profile.
• Experience preparing or executing IQ/OQ/PQ validation protocols and reports.
• Experience with Test Method Validation (TMV).
• Knowledge of measurement systems, calibration principles, MSA, and Gage R&R.
• Familiarity with pFMEA, CAPA, nonconformance investigations, change control, and root cause analysis.
• Experience using statistical tools such as Minitab for process or validation analysis.
• Exposure to equipment qualification, preventive maintenance, metrology, or calibration programs.
• Knowledge of GD&T and interpretation of engineering drawings is a plus

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

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