Senior Software Quality Engineer
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At a glance
Requirements
Credentials this posting asks for.
Job overview
DEKA Research & Development is hiring a Senior Software Quality Engineer. DEKA Research and Development is seeking a Senior Software Quality Assurance Engineer to support the development of life-changing medical devices. This role involves partnering with project managers and system engineers, leading requirement capture, and developing system-level test strategies. The engineer will also support the development and delivery of validated software tools, providing guidance based on experience in software product development or tool validation for medical devices.
Key focus areas include 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, and Develop system level test strategy, test specifications and test protocols.
Successful candidates bring MS/BS In Engineering, Computer Science Or Related Discipline, 5+ Years Experience In FDA Regulated Industry, and Experience Within Software Product Development Or Software Tool Validation Of Medical Devices. Important skills include Requirement Capture, System Level Test Strategy, Test Specifications, Test Protocols, Hazards Analysis, and Failure Modes Analysis. Preferred (not required): Requirements Definition and Requirements Management For Regulatory Compliance.
Skills & qualifications
Skills
Qualifications
Full job description
DEKA Research and Development, housed in Manchester, NH, is looking for a dynamic, results driven and inventive Senior Software Quality Assurance Engineer to support the development of life-changing medical devices.
How you will make an impact as a Senior Software Quality Engineer:
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Partner with Project Managers, System Engineers, Quality Systems Management & Information Technology to support the implementation of critical software tools.
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Lead requirement capture discussions to convert users’ needs into technical requirements.
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Develop system level test strategy, test specifications and test protocols
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Hazards analysis, failure modes analysis and mitigation design
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Support development / configuration of custom software tools
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Support device development teams through delivery of modern, validated software tools
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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:
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MS/BS in Engineering, Computer Science or related discipline with at least 5 years’ experience in an FDA regulated industry
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Working knowledge of FDA QSMR’s, ISO62304 and GAMP5
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Excellent organization, communication, and technical leadership skills
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Proficiency with Microsoft office tools: Word, Excel, PowerPoint, & Visio
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The ability to clearly write procedures that others can easily follow
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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 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.
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