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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.

Responsibilities:

  • 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

  • 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

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

  • Experience writing procedures for others to follow

  • Experience with data and failure analysis

  • Broad measurement instrument knowledge

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