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Validation Engineer III (Medical Devices)

TekOne IT Services Pvt. Ltd.
Plymouth, MN Full Time
POSTED ON 12/7/2024
AVAILABLE BEFORE 4/2/2025
Hello,

I Hope you are doing great.

This is Pavan from Intellectt INC; we’ve got an important Validation Engineer III - Plymouth, MN - 55442 with one of our prestigious clients. If you are interested, please share your updated resume to pavankumar@intellectt.com or call me at 1 (732) 276-1830

Role: Validation Engineer III

Location: Plymouth, MN - 55442

Duration: 06 Months on W2C

Summary

We are seeking a Method Validation Engineer with 2-5 years of experience in R&D or quality roles to support a project focused on validating test methods used in receiving inspection and production. The individual will develop and execute test method validation protocols, ensuring alignment with industry standards and regulatory requirements.

Key Responsibilities

  • Document existing test methods used in manufacturing processes.
  • Write and execute test method validation protocols with clear documentation and appropriate data analysis.
  • Ensure compliance by routing documentation within the company's quality management system.
  • Review existing quality system documentation and evaluate against current industry standards.

Education& Experience

    • Bachelor's degree in an Engineering discipline or other technical field.
    • Preferred: BS in Mechanical Engineering (ME) or Biomedical Engineering (BME) or other science-based fields.
    • Minimum 2-5 years in a related R&D or Quality role.
    • Expertise in test method development, including familiarity with industry standards.
    • Experience with test method validation, inspection method validation, and gage R&R.
    • Strong background in protocol development and report writing.
    • Ability to coordinate testing activities and manage documentation.
Skills

  • Exceptional attention to detail.
  • Competent in data analysis and application of statistical techniques.
  • Ability to document findings and communicate deviations clearly, with justification.

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