Job: Software Quality Assurance Engineer
Our client company’s mission is to enable a cure for the millions of patients suffering with atrial fibrillation (AF). They are developing a high-resolution, real-time, 3D electroanatomical mapping system that will be used during cardiac procedures to generate novel maps of AF using data acquired from an ultra-high-resolution catheter.
They are looking for an experienced Software Quality Assurance Engineer to join their 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 their 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 System 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
\- Vaccination against COVID-19 is required