Process Validation Engineer (Medical Devices)

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, we encourage you to apply and join us to create the extraordinary.

## 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

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## 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 [email protected] 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).