Medical Device Validation Engineer

About Defibtech:

Defibtech, LLC is a leading innovator in the field of Automated External Defibrillators (AEDs). The company designs and manufactures automated external defibrillators and related accessories. Products are sold exclusively through a network of distribution partners in the United Sates and around the world. In 2007 Defibtech was named the fastest-growing medical equipment company in North America by Deloitte and Touche USA. Defibtech is located in Guilford, Connecticut. 

About the Defibtech Medical Device Validation Engineer:

The Defibtech Medical Device Validation Engineer is responsible for verification and validation activities related to software controlled medical devices. These responsibilities include:Developing and executing Master Design Validation plans Developing and executing Design Verification and Validation protocols and reports for embedded software, hardware, and integrated systemsManaging SQA activities for embedded software systemsWorking with engineering, QA/QC and manufacturing personnel as requiredJob Requirements:

Experience in the medical device industry specifically in the area of design verification and validation and process validation of software controlled medical devices. Experience with ISO13485:2003, FDA, cGMP and software validation requirements. Must have good understanding of electronic product and software development life cycles and SQA.Must be able to execute projects through various stages of development with minimal supervisionExcellent organizational skills and the ability to manage multiple priorities, while working in a team environment