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 assigned projects
Perform verification testing following prescribed Test Cases for assigned projects.
Other duties within the scope of the Position Overview as assigned
Ensure compliance with regulatory standards and Insulet quality policies, procedures and practices

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), quality management system tool, test case management tool and, defect management tool

Systems Engineer – V&V

Key skills