Validation Mechanical Engineer

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

Job Summary

Mechanical Product Validation Engineer with 5-10 years of experience in the medical device industry specializing in cleaning sterilization and reprocessing validation of reusable medical devices. Skilled in feasibility studies validation protocols test method development GR&R risk management (DFMEA/PFMEA) statistical analysis and root cause investigations. Experienced in cross-functional collaboration to support compliant product development and successful product launches.

Responsibilities

Required Qualifications

• B.E./B.Tech in Mechanical Engineering or equivalent with 5-10 years of experience in the medical device industry.
• Hands-on expertise in cleaning sterilization and reprocessing validation for reusable medical devices.
• Proven experience in developing and validating cleaning and sterilization test methods including feasibility studies and validation protocols.
• Strong knowledge of validation methodologies including GR&R studies root cause analysis and statistical data evaluation.
• Experience supporting risk management activities design reviews and cross-functional product teams throughout the product development lifecycle.
• Familiarity with applicable regulatory and industry standards for reusable medical devices including validation and documentation requirements.
• Strong technical writing problem-solving and communication skills with the ability to collaborate effectively across engineering quality and regulatory functions.
• Develop soiling cleaning and extraction processes for reusable scopes and instruments and accessories (I&A) incorporating real world use conditions and cleanability considerations.

Job Responsibilities

• Plan execute and analyze Cleaning and Sterilization (C&S) feasibility studies cleanability assessments and sterilization validations for reusable scopes and I&A.
• Create and qualify test methods perform Gage Repeatability & Reproducibility (GR&R) studies and document results in engineering studies test protocols reports and validation documentation including statistical analysis as required.
• Conduct root cause analysis for C&S process issues and evaluation findings and communicate data driven solutions and recommendations to R&D and cross functional stakeholders.
• Support development and completion of associated risk management documentation (e.g. DFMEA PFMEA hazard analyses) by providing hands on laboratory expertise and technical input.
• Support Design Reviews and Phase Exit Reviews by preparing required documentation developing presentation materials and presenting technical content related to cleaning sterilization and reprocessing.
• Partner with internal teams and external supplier resources (e.g. test laboratories sterilization vendors) to ensure timely completion of product development and launch deliverables.