Principal Software Applications Engineer Onsite in Burlington MA

The Principal Software Applications Engineer is responsible for the design, development, and continuous improvement of systems and processes that support high-quality medical device and pharmaceutical production. This role involves cross-functional collaboration to ensure that products meet safety, regulatory, and performance standards from concept through commercialization. Key responsibilities include performing risk assessments, supporting validation and verification activities, troubleshooting manufacturing issues, and contributing to design transfer documentation. Strong knowledge of FDA regulations, ISO standards, and GMP guidelines is essential for success in this role.