Job Description

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.

RESPONSIBILITIES:

• Developing and writing 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 Assessments, Hazard Analyses, and FMEA’s
• Participating and contributing towards Regulatory and Agency submissions
• Authoring Test Summaries and other documents

REQUIREMENTS:

• BS degree in Physics, Electrical, Mechanical and/or Biomedical Engineering
• Experience with research, development, and product testing
• Experience writing procedures for others to follow
• Experience with data and failure analysis
• Broad measurement instrument knowledge
• 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 preferred

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