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Test Engineer

2 months ago

Marlborough, Massachusetts, United States Compunnel Inc. Full time
{"title": "Test Engineer", "content": "Job Summary

We are seeking a highly skilled Test Engineer to join our team at Compunnel Inc. in Marlborough, MA. As a Test Engineer, you will be responsible for designing and executing tests to validate the quality and performance of our products.

Key Responsibilities
  • Derive test requirements from specifications and define test plans and methodologies.
  • Estimate effort and resources to cover design verification and validation campaigns.
  • Establish acceptance criteria, sampling, and assess through modeling or qualitative/quantitative testing.
  • Write test protocols, set up design of experiments, execute tests, analyze results, and document reports.
  • Perform Test Method Validation and Equipment Qualification.
  • Lead root cause analysis and investigations on test failures.
Requirements
  • 7+ years of experience in Verification and Validation of processes with emphasis on new part development.
  • Developing and manufacturing plastic disposable kit products for a regulated industry (preferred medical device, class II and/or class III).
  • Mater's degree or equivalent experience in related engineering or scientific fields (mechanics, micro-mechanics, materials...).
  • Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820).
  • Demonstrated experience in defining and managing Verification and Validation plans, test execution, results risk mitigation, statistical data analysis, and reports.
What We Offer

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.

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