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Job

Manufacturing Test Engineer

  • Job ref:

    10410

  • Location:

    Manchester, United States

  • Sector:

    Manufacturing Engineers

  • Contact:

    Bob Giusti

  • Published:

    3 months ago

  • Consultant:

    #

Manufacturing Test Engineer - Verification & Validation

 

Manufacturing Test Engineer to work in a dynamic Medical Device R&D environment.  Responsibilities Include:

  • Design and manage product flow through existing Final Acceptance test operations
  • Train and manage a small team of testing technicians
  • Improve existing and develop new test procedures and equipment to drive throughput while assessing performance, durability, and reliability of the product
  • Understand device design and core technologies in order to inform test method development and aid engineering teams in troubleshooting
  • Define, develop and implement test fixtures and equipment needed for routine product testing.
  • Primary technical contact with outside suppliers of test equipment and fixtures.
  • Prepare test plans and methods for commercialization
  • Authoring Quality Plans, Test Summaries, and other documents
  • Define Process and Production Verification and Validation test procedures
  • Work with the Manufacturing teams to improve and implement Quality Assurance steps in upstream processes

Requirements:

  • BS degree in Electrical, Mechanical and/or Biomedical Engineering; BS in Physics acceptable with engineering experience.
  • 5 – 10 years’ experience in developing and implementing testing of complex electro-mechanical devices.
  • Strong knowledge and deep understanding of engineering fundamentals

Desired Qualifications:

  • Experience in medical devices, knowledge of FDA’s Quality System Regulations (QSR’s) and/or ISO 13485, and other medical device industry experience
  • Experience with new product introduction