Principal Software Development Engineer

Principal Software Development EngineerLocation: Bedford, MA USA (Onsite)Duration: Contract/Full TimeExperience: 5+ YearsThe Principal Software Development Engineer provides expertise in the design, development, characterization, and testing of complex application software used to drive and manage complex electromechanical medical devices. In this role you will interface with a strong multidisciplinary team across the full product development life cycle including requirements, risk, implementation and testing activities.Role OverviewDesign and develop application software following company and industry requirements and best practicesAssist in development of software subsystem architectures aligned to product level requirements and architectures including software requirements definitions and sub-system designsCollaboratively work with other engineering groups to translate system level requirements into product architectures making tradeoff decisions regarding hardware and software partitioningPerforms advanced risk analyses using FMEA and fault tree methods. Works with other engineering disciplines to develop, implement, and verify solutionsPerform software verification including code reviews, writing unit test cases, and running static analysisDocument system design inputs and outputs using the design control and document management systemEvaluates product performance on an on-going basis and initiates and evaluates required changes to the designs to improve and optimize performanceSolve complex software issues by analyzing critical factors and recommending corrective or alternative actionsEnsures adherence to company quality system, product specifications, industry standards, and quality and regulatory procedures and requirementsMaintains accurate documentation of concepts, designs, drawings, and processes through lab notebooks or other methodsExperienceBachelor’s Degree in Software or Electrical Engineering. Master’s degree preferred.5+ years Software Engineering experience in the design and development of complex, software driven electromechanical Class II medical devices; Class III experience preferredProfessional experience with.NET development platform - specifically C#, WPF, and/or MAUIExperience with C#/C++ multi-threadingExperience with Qt/QML based GUI development is desirableExperience with automated GUI testing is desirableExperience with the design and implementation of performant GUIs for imaging centric applications is desirablePrior experience with cloud integration with a focus on IoT type functionality is desirableDetailed knowledge of key regulatory requirements included ISO 13485, ISO 14971, ISO 62304 as well as FDA QSR 21 CFR Part 820 desirableExperience with electronic design control and document management systems preferredAbility to work independently with high competency and little guidance.