Process Validation Engineer (Medical Devices)

Flextronics - The Flex Company; Tequesquitlán; On-site; MXN 350,000 - 550,000; Full time

Benefits offered by this job

Pantry vouchers

Saving Fund

Christmas bonus

Holiday bonus

Medical Insurance

Life Insurance

Job summary

Flex is seeking a Process Validation Engineer (Medical Devices) to join our Juarez South operations. You will lead validation activities for manufacturing processes, equipment, and systems, and ensure compliance with FDA and ISO 13485 standards.

You will develop and execute validation protocols, support NPI, perform risk assessments, and collaborate with Quality, Manufacturing, Regulatory Affairs, and R&D to drive quality improvements and on-time deliverables.

Qualifications

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

Responsibilities

• Lead validation activities for manufacturing processes, equipment, and systems (IQ/OQ/PQ/TMV).
• Develop, execute, and approve validation protocols and reports to FDA/ISO 13485 and internal quality requirements.
• Support NPI activities, ensuring validation deliverables are completed on time.
• Evaluate process changes and determine validation impact, revalidation requirements.
• Perform statistical analysis and capability studies to support validation and continuous improvement.
• Collaborate with Quality, Manufacturing, Regulatory Affairs, and R&D.
• Conduct PFMEA-based risk assessments.
• Investigate process deviations, nonconformances, and CAPA activities.
• Support internal, customer, and regulatory audits with validation documentation.
• Develop and maintain validation master plans, protocols, reports, and docs.
• Identify and implement process improvements to enhance quality, compliance, productivity, and cost efficiency.

Skills

IQ/OQ/PQ/TMV validation

Statistics

PFMEA

CAPA investigations

Root cause

Cross-functional leadership

Project management

English proficiency

Education

Bachelor’s degree in Engineering

Job description

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment.

If you are excited about a role but don't meet every bullet point,

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we are 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:

• 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.

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.

Benefits

• 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.

Through the collective strength of ~150,000 team members across 30 countries and responsible, sustainable operations, Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career with Flex offers the opportunity to make a difference, invest in your growth, and build great products for our customers that improve people’s lives. Together, let’s create the extraordinary!