- Research Experience
- Communication Skills
- FDA Regulations
- Research & Development
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 multiple openings for Design Verification and Validation Test Engineers to work in a dynamic Medical Device Research and Development environment. Quality Assurance Test Engineering is a high visibility role with a significant direct impact on the success of the project.
Writing test plans, test procedures and other activities involving performance, durability, and reliability assessments
Understand device design and core technologies in order to inform test method development
Determining test coverage for revisions to design
Creating and evaluating test fixtures needed for product design verification
Contributing to design failure investigations that may impact Risk Assessment, Hazard Analysis, and FTA's
Participating and contributing towards Regulatory and Agency submissions
Authoring Quality Plans, Test Summaries, and other documents
BS degree in Physics, Electrical, Mechanical and/or Biomedical Engineering
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 be 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 a research, development, and product testing.
Experience writing procedures for others to follow
Experience with data and failure analysis
Broad measurement instrument knowledge