For further inquiries regarding the following opportunity, please contact our Talent Specialist:
Nithiya at (224) 507 1292
Ragu Mohan at (630) 847-0953
Title: Test Method Validation Engineer
Duration: 6 Months
Location: On-site at San Diego, CA
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
This position requires U.S. Citizens only to meet the DoD requirements.
• Develop and validate test methods to ensure compliance with internal and external standards.
• Lead Test Method Validation (TMV) activities, including protocol development, execution, and reporting.
• Conduct Measurement System Analysis (MSA) including Gage Repeatability and Reproducibility (GR&R) studies to assess and improve measurement reliability.
• Collaborate cross-functionally with R&D, Quality, and Manufacturing teams to ensure test methods meet product and business requirements.
• Analyze data using statistical tools to evaluate method performance and identify areas for improvement.
• Author and maintain validation documentation, including protocols, reports, and risk assessments.
• Flexibility to work off shifts and overtime based on equipment availability.
• Strong problem-solving skills when validating both destructive and non-destructive test methods.
• Highly familiar with vision-based metrology equipment
• Have a preventative mindset through anticipating potential problems.
• Excellent written and oral communication skills.
• Proficiency in statistical analysis software (e.g., JMP, Minitab)
• Experience with project management tools such as JIRA, Confluence, and Smartsheet.
• Seeking an experienced Test Engineer/manufacturing engineer/ process engineer/ Quality engineer / Mechanical engineer with a minimum of 5 years in testing and manufacturing environments.
• The ideal candidate will lead GR&R and TMV studies, develop and validate testing processes, and design mechanical fixtures to support product verification and production readiness.
Key Responsibilities:
• Conduct GR&R, TMV, and measurement system analysis.
• Drive process development using DOE methodologies.
• Design and develop mechanical fixtures using CAD tools with strong GD&T application.
• Collaborate with cross-functional teams to ensure test accuracy and compliance with FDA standards.
• Perform data analysis and reporting using JMP or Minitab.
• Medical devices experience is a plus (Preferred)
Qualifications:
• Bachelor’s degree in Mechanical, Manufacturing, or related Engineering field.
• 5+ years of hands-on experience in testing, measurement, and process development.
• Strong understanding of FDA-regulated manufacturing environments.