Verification & Validation Test Engineer
DEKA Research & Development · Manchester, NH ·
- Category
- QA
Designs and executes verification and validation testing for electro-mechanical medical devices—writing test plans/procedures, evaluating fixtures, and contributing to regulatory submissions in a lab-based R&D environment.
DEKA Research & Development, located in Manchester, NH, is seeking a Verification & Validation Test Engineer to work in a dynamic medical device R&D environment. This is a high visibility role with a direct impact on the success of our projects. It will be a great opportunity to work on some amazing projects that make a positive impact on the world. Do you want to make a difference with your work? At DEKA you can!
How you will make an impact as a Verification & Validation Test Engineer:
- 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 FTAs
- Participating and contributing toward regulatory and agency submissions
- Authoring Quality Plans, Test Summaries, and other documents
What you need to be successful Verification & Validation Test Engineer:
- BS in Biomedical, Mechanical, Electrical and/or Robotics/ Automation Engineering
- 3+ years' experience testing electro-mechanical devices (medical devices preferred)
- Must have fluid system handling experience
- Leadership and/or mentoring experience
- Knowledge and deep understanding of engineering fundamentals
- Capability to create and clearly explain team objectives and write procedures for others to follow
- Demonstrated problem solving ability and techniques
- Ability to work as part of an interdisciplinary team
- Self-motivated and able to self-prioritize
- Must have excellent verbal and written communication skills
Preferred skills and experience:
- Knowledge of FDA Quality System Regulations (QSRs) and/or ISO 13485, and other medical device industry experience
- Experience with research, development, and product testing
- Experience writing procedures for others to follow
- Experience with data and failure analysis
- Broad measurement instrument knowledge
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.