System Engineer V&v

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 itJob Profile SummaryJob 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 testing, system testing, material testing, 3rd party (agency) testing, shelf life and aging testing, simulated use, and drug-device compatibility testing.The 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 and Validation Plans for assigned projects- Develop detailed Verification schedules utilizing time based resourced management tools- Perform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools (DOORs, Helix, Jama).- Collaborate with Systems Engineers in Systems Engineering COE to ensure that all requirements are testable- 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- Conduct and encourage frequent formal and informal communication with team members to ensure full engagement and efficient operation.- Analyze design changes implemented after execution of verification and validation to determine regression testing required- Provide technical consulting and mentoring in areas of expertise to early-career members of the Design Verification Test Team- 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)- Develop new Test Cases and/or update existing Test Cases to match requirement updates and new understanding of system performance- 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- Perform verification testing following proscribed Test Cases for assigned projects.- Other duties within the scope of the Position Overview as assigned- Ensure compliance with Insulet quality policies, procedures and practices- Ensure compliance with all local, state and federal regulations, policies and procuresEducation 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 experiencePreferred Skills and Competencies:- Strong technical judgement with extensive technical leadership skills- Demonstrated capability of leading Verification & Validation Test Programs- Excellent Program Management Skills - PMP Certification a plus- Previous experience working in an Agile based Software Development environment strongly preferred.- Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.- Experience guiding team/individuals to develop technical solutions to complex problems- Sound knowledge of engineering first principals- Strong Analytical and Problem-Solving Skills- Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams- Experience in directing associates and leading small cross-functional teams- Good written and verbal communication skills- Familiarity with System Level Testing of software based Medical Devices- Test Engineering training and/or certification is a plus- Previous experience with National Instruments LabView, CVI, Test Stand and/or Measurement Studio is a big plus- Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory