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
- 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 plus
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.
Skills Required
- MS/BS in Engineering, Computer Science or related discipline
- 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
- Experience with requirements definition and management for regulatory compliance
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
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