DEKA Research & Development, located in Manchester, NH, is seeking a Senior Systems Validation 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:
Writing test plans, test procedures and other activities involving performance, durability, and reliability assessmentsUnderstand device design and core technologies in order to inform test method developmentDetermining test coverage for revisions to designCreating and evaluating test fixtures needed for product design verificationContributing to design failure investigations that may impact Risk Assessment, Hazard Analysis, and FTAsParticipating and contributing toward regulatory and agency submissionsAuthoring Quality Plans, Test Summaries, and other documentsWhat you need to be successful:
BS in Physics, Electrical, Mechanical and/or Biomedical Engineering3+ years' experience testing electro-mechanical medical devicesLeadership and/or mentoring experience Knowledge and deep understanding of engineering fundamentalsCapability to create and clearly explain team objectives and write procedures for others to followDemonstrated problem solving ability and techniquesAbility to work as part of an interdisciplinary teamSelf-motivated and able to self-prioritizeMust have excellent verbal and written communication skillsPreferred skills and experience:
Knowledge of FDA Quality System Regulations (QSRs) and/or ISO 13485, and other medical device industry experienceExperience with research, development, and product testingExperience writing procedures for others to followExperience with data and failure analysisBroad measurement instrument knowledgeAbout 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.