Systems 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.

Job Description

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 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

Education and Experience:

·       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

Preferred Skills and Competencies:         

·       Strong 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.

·       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

·       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