Insulet
SystemsEngineer,V&V
Neural analysis suggests this role is
optimal for Mid candidates.
“Systems Engineer, V&V at Insulet. Skills: Verification, Validation, Systems Engineering, Test Cases. Manage Verification and Validation activities. Develop Verification and Validation Plans”
Industry & Context.
Analytical and Problem-Solving Skills
What They're Looking For.
Must Have
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, Experience working with a requirements management tool (Helix, Jama, and/or Polarion), Experience working with a quality management system tool, Experience working with a test case management tool, Experience working with a defect management tool
Nice to Have
technical judgement with technical leadership skills, Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process, 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, Demonstrated skills testing FDA-regulated medical devices (Class 2 or 3) under Design Controls, Experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971
What You'll Do.
Manage Verification and Validation activities
Develop Verification and Validation Plans
Develop Verification schedules
Perform requirements analysis
Manage Test Cases and Test Runs
Collaborate with Systems Engineering
Develop test strategies
Analyze design changes
Provide technical consulting
Manage 3rd party verification activities
Perform product configuration management
Perform verification testing
Ensure compliance with regulatory standards
How You'll Work.
Team & Collaboration
Collaborate with Systems Engineering; technical consulting and mentoring; leading small cross-functional teams
Communication Scope
Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams; Good written and verbal communication skills
Process & Methodology
Manage all Verification and Validation activities, Develop detailed Verification schedules, Manage 3rd party verification activities, Perform product configuration management
Full Job Description
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! The 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. **Responsibilities:** · Manage all Verification and Validation activities and deliverables for New Product Development and sustaining products. · Develop detailed Verification and Validation Plans for assigned projects · Develop detailed Verification schedules utilizing time based resource management tools · Perform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools. · Collaborate with Systems Engineering to ensure that all requirements are testable · Develop, 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 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) · Perform and maintain product configuration management for assigne
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