Senior Software Quality Engineer

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.

• 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.

• 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, ISO
  62304 and GAMP
  5.
• 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 plus.