Systems Engineer V&V managing verification and validation activities in medical device development at Insulet. Responsible for leading system engineering for verification and validation in cross-functional teams.
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
Collaborate with Systems Engineering in Systems Engineering COE to ensure that all requirements are testable
Create and document novel and robust test methodologies
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
Perform systemic reviews of test cases to ensure complete coverage of typical use and edge cases scenarios
Requirements
Bachelors’ Degree in Biomedical Engineering, Software Engineering, Systems Engineering, Computer Science, 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
Strong technical judgement with extensive technical leadership skills
Familiarity with System Level Testing of software based Medical Devices
Experience with design and development processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, ISO 14971 and ISO 9000
Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.
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