.Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!Job Title:Systems Engineer V&VDepartment:Systems Engineering COEFLSA Status:ExemptPosition Overview:The Systems Engineer V&V is a member of the Systems Engineering COE and a technical expert responsible for leading Systems Engineering activities related to verification and validation of Insulet's products. Education and work experience should encompass a wide array of engineering disciplines relevant to:Mechanical testingSystem testingMaterial testing3rd party (agency) testingShelf life and aging testingSimulated useDrug-device compatibility testingThe position will report to the Manager Systems Design Verification, Systems Engineering COE, Medical Devices R&D located at Insulet's Headquarters in Acton, MA.Responsibilities:Manage all Verification and Validation activities and deliverables for New Product Development and Lifecycle Project Teams.Develop detailed Verification schedules utilizing time based resource management tools.Perform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools (DOORs, Helix, Jama).Participate in the planning and execution of technical project work.Create and document novel and robust test methodologies and provide feedback and recommendations for product/design changes.Analyze design changes implemented after execution of verification and validation to determine regression testing required.Manage 3rd party verification activities to ensure product is fully compliant with all applicable standards (i.E. IEC/AAMI/UL 60601-1, 1-2 and applicable collateral standards).Perform dry-running of new and updated Test Cases.Perform systemic review of Test Cases to ensure that both typical use and edge cases are properly covered (happy-path, alternate path, negative path, etc.).Perform and maintain product configuration management for assigned projects.Ensure compliance with Insulet quality policies, procedures and practices.Ensure compliance with all local, state and federal regulations, policies and procedures.Education and Experience:Minimum Requirements:Bachelors' Degree in Biomedical Engineering, Software Engineering, Computer Science, Mechanical, Electrical Engineering or a related field.Minimum of 3 years' experience testing medical devices in a multidisciplinary project team environment or advanced degree and 1+ years of experience