Job SummaryJob DescriptionThe Systems Engineer V&V will be a member of the Systems Engineering COE responsible for Systems Engineering activities related to verification and validation of Insulet's products.The position will report to the Manager Systems Design Verification located at Insulet's office in Tijuana, Baja California, Mexico.ResponsibilitiesManage all Verification and Validation activities and deliverables for New Product Development and sustaining products.Develop detailed Verification and Validation Plans for assigned projectsDevelop detailed Verification schedules utilizing time based resource management toolsPerform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools.Collaborate with Systems Engineering to ensure that all requirements are testableDevelop, review, implement and maintain test strategies, test protocols and test cases for system verification.Analyze design changes implemented after execution of verification and validation to determine regression testing requiredProvide technical consulting and mentoring in areas of expertise to early-career members of the Design Verification Test TeamManage 3rd party verification activities to ensure product is fully compliant with all applicable standards (i.e. IEC/AAMI/UL *, 1-2 and applicable collateral standards)Perform and maintain product configuration management for assigned projectsPerform verification testing following prescribed Test Cases for assigned projects.Other duties within the scope of the Position Overview as assignedEnsure compliance with regulatory standards and Insulet quality policies, procedures and practicesEducation And ExperienceBachelors' 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 experienceExperience working with a requirements management tool (Helix, Jama, and/or Polarion), quality management system tool, test case management tool and, defect management toolPreferred Skills And CompetenciesStrong technical judgement with technical leadership skillsFamiliarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.Strong Analytical and Problem-Solving SkillsAbility to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teamsExperience in directing associates and leading small cross-functional teamsGood written and verbal communication skillsFamiliarity with System Level Testing of software based Medical DevicesTest Engineering training and/or certification is a plusDemonstrated skills testing FDA-regulated medical devices (Class 2 or 3) under Design ControlsExperience with design and development processes that conform to standards such as ISO , ISO *, IEC *, IEC *, and ISO *Insulet started in 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!
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