DEKA Research and Development housed in Manchester NH is looking for a dynamic results driven and inventive Senior Software Quality 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
- Proficientwith FDA QSRs 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 Engineerto support the development of life-changing medical devices.How you will make an impact as a Senior Software Quality Engineer:Partner with P...
DEKA Research and Development housed in Manchester NH is looking for a dynamic results driven and inventive Senior Software Quality 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
- Proficientwith FDA QSRs 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
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