Medical Device Validation Engineer

HCLTech; Tijuana; On-site; MXN 859,402 - 1,203,162; Full time

Job summary

HCLTech is looking for a Validation Engineer in Tijuana, Baja California. The role involves executing end-to-end validation and re-validation activities for processes, test methods, and measurement systems. The ideal candidate holds a Bachelor’s degree in a related engineering field and has 2–5 years of relevant experience in validation engineering. Knowledge of regulatory standards like ISO 13485 and hands-on experience with validation documentation is essential. Join HCLTech to contribute to industry-leading technology services.

Qualifications

• Bachelor’s degree in relevant engineering field.
• Strong understanding of validation principles including IQ/OQ/PQ.
• Knowledge of ISO 13485 and FDA regulations.

Responsibilities

• Develop and execute validation plans and protocols.
• Perform process validation and test method validation.
• Update validation documents and maintain records in QMS.

Skills

Validation principles (IQ/OQ/PQ)

Test Method Validation (TMV)

Measurement System Analysis (MSA)

Analytical skills

Statistical skills

Education

Bachelor’s degree in mechanical, industrial, biomedical, or related engineering field

Tools

Minitab

JMP

Job description

HCLTech is looking for a Validation Engineer in Tijuana, Baja California. The role involves executing end-to-end validation and re-validation activities for processes, test methods, and measurement systems. The ideal candidate holds a Bachelor’s degree in a related engineering field and has 2–5 years of relevant experience in validation engineering. Knowledge of regulatory standards like ISO 13485 and hands-on experience with validation documentation is essential. Join HCLTech to contribute to industry-leading technology services.