Boston, Massachusetts20 days ago
Must possess at least five (5) years of experience with each of the following: Coordination of cross functional groups for quality objectives around product software, quality system , and software technologies for medical devices; MDPD, SDLC, FDA 21 CFR Part 11 and Part 820, ISO 13485, ISO 14971, and IEC 62304; AAMI TIR45, C, C++, C#, Python and SQL; Minitab; SFMEA and SFTA; Review, analyze, and disposition of Software Defects and Software Problem Reports (SPRs); Software validation processes including Software Cybersecurity, Medical Device Design Controls, Design History File and Product Life Cycle; and Software validation, Test Methods Development, Automation testing, & V&V of product software. Bachelors’ Degree in Information Technology, Computer Science, Software Engineering or related technical or engineering field and seven (7) years of experience as a software engineer or related occupation in software engineering or Master’s Degree in Information Technology, Computer Science, Software Engineering or related technical or engineering field and five (5) years of experience as a software engineer or related occupation software engineering.