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DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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Nithiya at
Title: Test Method Validation Engineer
Duration: 6 Months
Location: On-site at San Diego, CA
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.
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)
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.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.