Manchester, United States
about 2 years ago
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
- 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
- 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