Software Quality Assurance Engineer

Job Description

Position: Software Quality Assurance Engineer
The Software Quality Assurance Engineer will join our growing team and own the product software development and validation activity for the Quality Assurance department in a dynamic and complex engineering environment. This role is based full time in our Burlington, MA office. A hybrid assignment of remote and onsite work may be considered on a case-by-case basis.

RESPONSIBILITIES

• Assist the design team in software development activity - planning, requirement development (input), software design output, change/configuration management, risk management, design reviews, and releases
• Review and approve software product documentation (SRS, SDS)
• Own software validation testing activity and associated documentation
• Design test strategies; write test plans and test cases
• Validate automated tests and development/production tools
• Log and verify bugs, aid in associated root cause investigation and corrective action activity

SKILLS AND EXPERIENCE

• 5+ years experience with New Product Development (NPD) of a software medical device including completion of software validation for a regulatory submission is required
• Working knowledge of current regulatory industry standard requirements for administration of design control and validation elements of the Quality Systems in alignment with FDA 21 CFR Part 11 & Part 820, ISO 13485:2016, and IEC 62304:2006 is required
• Proven experience creating Software Development Life Cycle (SDLC) procedures is required
• The ability to write and maintain requirements through a software development project is required
• Experience with SDLC tool selection and validation is required
• Familiarity with complex UI development and validation is required
• Effective verbal and written communication skills are required
• Strong organizational, problem-solving, and analytical skills are required
• Comfortable working in both a rigorous early-stage environment with fluid requirements, as well as a regulated later-stage process-driven setting is preferred
• Bachelor of Computer Science or a related field is preferred