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