Process Validation Engineer (Medical Devices)

847 Flextronics Manufacturing Juarez S De Rl De Cv; Ciudad Juárez; On-site; MXN 380,000 - 660,000; Full time

Benefits offered by this job

Pantry vouchers

Saving Fund

Christmas bonus

Holiday bonus

Medical Insurance

Life Insurance

Job summary

847 Flextronics Manufacturing Juarez S De Rl De Cv is seeking a Process Validation Engineer (Medical Devices) in Juarez South. You will lead validation activities, develop protocols, and support FDA/ISO 13485 compliance while coordinating with Quality, Manufacturing, Regulatory Affairs, and R&D.

The role requires a mechanical/industrial/biomedical engineering background, 3–5 years in regulated environments, and advanced English communication.

Qualifications

• Bachelor's degree in engineering (Mechanical, Industrial, Biomedical, Manufacturing, Mechatronics, or related field).
• Advanced English communication skills.
• Minimum 3-5 years of experience in medical devices, pharmaceutical, or regulated manufacturing environments.
• Strong experience executing and managing IQ, OQ, PQ, and processing validation activities.
• Proficiency in statistical tools, process capability studies, and data analysis.
• Knowledge of risk management methodologies, including PFMEA.
• Experience with CAPA, nonconformance investigations, and root cause analysis methodologies.
• Strong project management and cross-functional leadership skills.

Responsibilities

• Lead validation activities for manufacturing processes, equipment, and systems, including IQ, OQ, PQ, and TMV studies.
• Develop, execute, and approve validation protocols and reports in compliance with FDA, ISO 13485, and internal quality requirements.
• Support New Product Introduction (NPI) activities, ensuring validation deliverables are completed on time.
• Evaluate process changes and determine validation impact assessments and revalidation requirements.
• Perform statistical analysis and capability studies to support process validation and continuous improvement initiatives.
• Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and R&D.
• Conduct risk assessments using PFMEA and other risk management tools.
• Investigate process deviations, nonconformances, customer complaints, and CAPA activities.
• Support internal, customer, and regulatory audits by providing validation documentation and technical expertise.
• Develop and maintain validation master plans, protocols, reports, and associated documentation.
• Identify and implement process improvements that enhance quality, compliance, productivity, and cost efficiency.

Skills

IQ/OQ/PQ validation

Statistical analysis

PFMEA risk management

CAPA investigations

Cross-functional leadership

Advanced English

Education

Bachelor's degree in engineering

Tools

Statistical software

Quality systems training

Job description

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Process Validation Engineer (Medical Devices) located in Juarez South.

Reporting to the Process Engineering Manager, the Process Engineer’s role involves:

What a typical day looks like:

• Lead validation activities for manufacturing processes, equipment, and systems, including IQ, OQ, PQ, and TMV studies.
• Develop, execute, and approve validation protocols and reports in compliance with FDA, ISO 13485, and internal quality requirements.
• Support New Product Introduction (NPI) activities, ensuring validation deliverables are completed on time.
• Evaluate process changes and determine validation impact assessments and revalidation requirements.
• Perform statistical analysis and capability studies to support process validation and continuous improvement initiatives.
• Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and R&D.
• Conduct risk assessments using PFMEA and other risk management tools.
• Investigate process deviations, nonconformances, customer complaints, and CAPA activities.
• Support internal, customer, and regulatory audits by providing validation documentation and technical expertise.
• Develop and maintain validation master plans, protocols, reports, and associated documentation.
• Identify and implement process improvements that enhance quality, compliance, productivity, and cost efficiency.

The experience we’re looking to add to our team:

• Bachelor’s degree in engineering (Mechanical, Industrial, Biomedical, Manufacturing, Mechatronics, or related field).
• Advanced English communication skills.
• Minimum 3-5 years of experience in medical devices, pharmaceutical, or regulated manufacturing environments.
• Strong experience executing and managing IQ, OQ, PQ, and processing validation activities.
• Proficiency in statistical tools, process capability studies, and data analysis.
• Knowledge of risk management methodologies, including PFMEA.
• Experience with CAPA, nonconformance investigations, and root cause analysis methodologies.
• Strong project management and cross-functional leadership skills.

What you’ll receive for the great work you provide:

• Pantry vouchers
• Saving Fund
• Christmas bonus
• Holiday bonus
• Medical Insurance
• Life Insurance

EM57

Job Category

Production Engineering

Required Skills:

Optional Skills:

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).