Systems Engineer, V&V

<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left">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.</p><div><div><div><div><p style="text-align:inherit"></p><p style="text-align:left">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!</p></div></div></div></div><p style="text-align:inherit"></p><p><span>The Systems Engineer V&amp;V will be a member of the Systems Engineering COE responsible for Systems Engineering activities related to verification and validation of Insulet’s products.</span></p><p><span>The position will report to the Manager Systems Design Verification  located at Insulet’s office in Tijuana, Baja California, Mexico.</span></p><p></p><p><span><b>Responsibilities:</b></span></p><p><span>·       Manage all Verification and Validation activities and deliverables for New Product Development and sustaining products.</span></p><p><span>·       Develop detailed Verification and Validation Plans for assigned projects</span></p><p><span>·       Develop detailed Verification schedules utilizing time based resource management tools</span></p><p><span>·       Perform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools.</span></p><p><span>·       Collaborate with Systems Engineering to ensure that all requirements are testable</span></p><p><span>·       Develop, review, implement and maintain test strategies, test protocols and test cases for system verification. </span></p><p><span>·       Analyze design changes implemented after execution of verification and validation to determine regression testing required</span></p><p><span>·       Provide technical consulting and mentoring in areas of expertise to early-career members of the Design Verification Test Team</span></p><p><span>·       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)</span></p><p><span>·       Perform and maintain product configuration management for assigned projects</span></p><p><span>·       Perform verification testing following prescribed Test Cases for assigned projects.</span></p><p><span>·       Other duties within the scope of the Position Overview as assigned</span></p><p><span>·       Ensure compliance with </span><span><span>regulatory standards and</span></span><span> Insulet quality policies, procedures and practices</span></p><p></p><p><span><b>Education and Experience:</b></span></p><p></p><p><span>·       Bachelors’ Degree in Biomedical Engineering, Software Engineering, Computer Science, Mechanical, Electrical Engineering or a related field.</span></p><p><span>·       Minimum of 3 years’ experience testing medical devices in a multidisciplinary project team environment or advanced degree and 1&#43; years of experience</span></p><p><span>·       </span><span><span>Experience working with a requirements management tool (Helix, Jama, and/or Polarion), quality management system tool, test case management tool and, defect management tool</span></span></p><p></p><p><span><b>Preferred Skills and Competencies:         </b></span></p><p><span>·       Strong technical judgement with technical leadership skills</span></p><p><span>·       Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.</span></p><p><span>·       Strong Analytical and Problem-Solving Skills</span></p><p><span>·       Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams</span></p><p><span>·       Experience in directing associates and leading small cross-functional teams</span></p><p><span>·       Good written and verbal communication skills</span></p><p><span>·       Familiarity with System Level Testing of software based Medical Devices</span></p><p><span>·       Test Engineering training and/or certification is a plus</span></p><p><span>·       Demonstrated skills testing FDA-regulated medical devices (Class 2 or 3) under Design Controls</span></p><p><span>·       Experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971</span></p><p><span><b>Physical Requirements (if applicable):          </b></span></p><p><span>·       Not Applicable</span></p>