Boston, Massachusetts18 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. Basic Qualifications: 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 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 in software engineering.