Process Validation Engineer (Medical Devices)

Flex; Ciudad Juárez; Presencial; MXN 700.000 - 1.000.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Pantry vouchers

Saving Fund

Christmas bonus

Holiday bonus

Medical Insurance

Life Insurance

EM57

Descripción de la vacante

Flex is seeking a Process Validation Engineer (Medical Devices) to join our Juarez South team. You will lead IQ/OQ/PQ/TMV validation activities for processes, equipment and systems, ensuring compliance with FDA and ISO 13485 requirements.

You will collaborate with Quality, Manufacturing, Regulatory Affairs and R&D to support NPI, perform risk assessments, and drive CAPA investigations while developing validation master plans and reports.

Formación

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

Responsabilidades

• Lead validation activities for processes, equipment, and systems (IQ, OQ, PQ, TMV).
• Develop, execute, and approve validation protocols and reports per FDA/ISO 13485.
• Support NPI with timely validation deliverables.
• Perform risk assessments using PFMEA and other tools.
• Conduct statistical analysis and capability studies for validation.
• Collaborate with Quality, Manufacturing, Regulatory Affairs, and R&D.
• Investigate deviations, nonconformances, CAPA activities.
• Prepare validation master plans, protocols, and reports.
• Assist audits with validation documentation and expertise.
• Identify process improvements for quality, productivity, and cost.

Conocimientos

Advanced English

Cross-functional leadership

Project management

Educación

Engineering degree

Herramientas

Statistical analysis tools

PFMEA

Descripción del empleo

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.

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

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.