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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
p FMEA, 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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📌 Ingeniero De Manufactura I (Chihuahua)
🏢 Mx3 Cov - Mkdt Respiratory Mexico
📍 Chihuahua