DEKA Research & Development Manufacturing Test Engineer - Verification & Validation in Manchester, New Hampshire
DEKA employs a team whose engineering, design, manufacturing and quality expertise make DEKA a hot spot for creating innovative solutions and advanced technologies. Located about an hour from Boston, the beach, and the mountains, DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time.
We have an opening for a Manufacturing Test Engineer to work in a dynamic Medical Device Research and Development environment. The Manufacturing Test Engineer is a high visibility role with a significant direct impact on the success of clinical trials and commercial launch. There is potential for this role to grow with the product from pilot to commercial manufacturing scales.
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
Demonstrated problem solving ability and techniques
Ability to work as part of an interdisciplinary team
Self-motivated and able to self-prioritize
Ability to clearly explain objectives
Must have excellent verbal and written communication skills
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
Experience writing procedures for others to follow
Experience with data and failure analysis
Broad measurement instrument knowledge