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 assistance
To 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 QSMRs 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
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 DEKAs 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.
Required Experience:
Senior IC
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:Part...
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 assistance
To 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 QSMRs 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
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 DEKAs 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.
DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it
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