Senior Software Quality Engineer
About The Position
DEKA Research and Development, housed in Manchester, NH, is looking for a dynamic, results driven and inventive Senior Software Quality Engineer to 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 assistance 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.
Requirements
- MS/BS in Engineering, Computer Science or related discipline with at least 5 years’ experience in an FDA regulated industry
- Proficient with FDA QSR’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
Nice To Haves
- Experience with requirements definition and management for regulatory compliance a plus
Responsibilities
- 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 assistance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
