Senior Software Quality Engineer

DEKA Research and Development, housed in Manchester, NH, is looking for a dynamic, results driven and inventive Senior Software Quality Assurance Engineerto support the development of life-changing medical devices.

How you will make an impact as a Senior Software Quality Engineer:

Partner with Project Managers, System Engineers, Quality Systems Management & Information Technology to support the implementation of critical software tools.

Lead requirement capture discussions to convert users' needs into technical requirements.

Develop system level test strategy, test specifications and test protocols

Hazards analysis, failure modes analysis and mitigation design

Support development / configuration of custom software tools

Support device development teams through delivery of modern, validated software tools

Use experience within software product development or software tool validation of medical devices to provide guidance and assistanceTo be successful in this role, you will need the following skills and experience:

MS/BS in Engineering, Computer Science or related discipline with at least 5 years' experience in an FDA regulated industry

Working knowledge of FDA QSMR's, ISO62304 and GAMP5

Excellent organization, communication, and technical leadership skills

Proficiency with Microsoft office tools: Word, Excel, PowerPoint, & Visio

The ability to clearly write procedures that others can easily follow

Experience with requirements definition and management for regulatory compliance a plusAbout 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.