Mechanical Validation Engineer – Medical Devices (C&S)

Cognizant; Ciudad Juárez; On-site; MXN 450,000 - 650,000; Full time

Job summary

Cognizant in Ciudad Juárez, Mexico is seeking a Mechanical Product Validation Engineer with 5-10 years in the medical device sector, specializing in cleaning sterilization and reprocessing validation of reusable devices.

You will plan feasibility studies, develop and validate test methods, perform GR&R and statistical analyses, and support DFMEA/PFMEA and risk management to enable compliant product launches.

Qualifications

• 5-10 years of experience in the medical device industry.
• Hands-on expertise in cleaning sterilization and reprocessing validation.
• Experience developing validation protocols and test methods.
• Knowledge of GR&R, DFMEA/PFMEA, and regulatory requirements.

Responsibilities

• Plan, execute, and analyze C&S feasibility studies and sterilization validations for reusable devices.
• Develop and qualify test methods; perform GR&R studies and interpret results.
• Conduct root-cause analysis for C&S issues and recommend data-driven solutions.
• Support risk management documentation (DFMEA/PFMEA) with lab input.
• Prepare design reviews and phase exits with cleaning/sterilization content.
• Coordinate with internal teams and external labs to meet validation milestones.

Skills

Cleaning & sterilization validation

GR&R studies

DFMEA/PFMEA

Statistical analysis

Root cause investigations

Cross-functional collaboration

Regulatory/documentation

Education

B.E./B.Tech in Mechanical Engineering

Job description

Cognizant in Ciudad Juárez, Mexico is seeking a Mechanical Product Validation Engineer with 5-10 years in the medical device sector, specializing in cleaning sterilization and reprocessing validation of reusable devices.

You will plan feasibility studies, develop and validate test methods, perform GR&R and statistical analyses, and support DFMEA/PFMEA and risk management to enable compliant product launches.