For further inquiries regarding the following opportunity, please contact our Talent Specialist:
Nithiya at (224) 507 1292
Ragu Mohan at (630) 847-0953ย
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Title: Test Method Validation Engineer ย
Duration: 6 Months
Location: On-site at San Diego, CA
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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.
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โข Develop and validate test methods to ensure compliance with internal and external standards.
โข LeadโฏTest Method Validation (TMV)โฏactivities, including protocol development, execution, and reporting.
โข ConductโฏMeasurement System Analysis (MSA)โฏincludingโฏGage Repeatability and Reproducibility (GR&R)โฏstudies to assess and improve measurement reliability.
โข Collaborate cross-functionally with R&D, Quality, and Manufacturing teams to ensure test methods meet product and business requirements.
โข Analyze data using statistical tools to evaluate method performance and identify areas for improvement.
โข Author and maintain validation documentation, including protocols, reports, and risk assessments.
โข Flexibility to work off shifts and overtime based on equipment availability.
โข Strong problem-solving skills when validating both destructive and non-destructive test methods.
โข Highly familiar with vision-based metrology equipment
โข Have a preventative mindset through anticipating potential problems.
โข Excellent written and oral communication skills.
โข Proficiency in statistical analysis software (e.g., JMP, Minitab)
โข Experience with project management tools such as JIRA, Confluence, and Smartsheet.
โข Seeking an experienced Test Engineer/manufacturing engineer/ process engineer/ Quality engineer / Mechanical engineer with a minimum of 5 years in testing and manufacturing environments.ย
โข 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.
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Key Responsibilities:
โข Conduct GR&R, TMV, and measurement system analysis.
โข Drive process development using DOE methodologies.
โข Design and develop mechanical fixtures using CAD tools with strong GD&T application.
โข Collaborate with cross-functional teams to ensure test accuracy and compliance with FDA standards.
โข Perform data analysis and reporting using JMP or Minitab.
โข Medical devices experience is a plus (Preferred)
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Qualifications:
โข Bachelorโs degree in Mechanical, Manufacturing, or related Engineering field.
โข 5+ years of hands-on experience in testing, measurement, and process development.
โข Strong understanding of FDA-regulated manufacturing environments.