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Systems Engineer V&V Lead
hace 2 meses
Insulet is a leading medical device company that has been improving the lives of hundreds of thousands of patients with its innovative Omnipod product platform. We are seeking a highly motivated and experienced Systems Engineer V&V Lead to join our expanding team.
Job Summary:The Systems Engineer V&V Lead will be a key member of our Systems Engineering COE, responsible for leading Verification and Validation activities related to Insulet's products. This role requires a strong technical background, excellent leadership skills, and the ability to effectively communicate with cross-functional teams.
Key Responsibilities:- Manage all Verification and Validation activities and deliverables for New Product Development and Lifecycle Project Teams.
- Develop detailed Verification schedules utilizing time-based resourced management tools.
- Perform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools (DOORs, Helix, Jama).
- Participate in the planning and execution of technical project work.
- Create and document novel and robust test methodologies and provide feedback and recommendations for product/design changes.
- Analyze design changes implemented after execution of verification and validation to determine regression testing required.
- Manage 3rd party verification activities to ensure product is fully compliant with all applicable standards (i.e. IEC/AAMI/UL, 1-2 and applicable collateral standards).
- Perform dry-running of new and updated Test Cases.
- Perform systemic review of Test Cases to ensure that both typical use and edge cases are properly covered (happy-path, alternate path, negative path, etc.).
- Perform and maintain product configuration management for assigned projects.
- Ensure compliance with Insulet quality policies, procedures, and practices.
- Ensure compliance with all local, state, and federal regulations, policies, and procedures.
- Bachelor's 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.
- Strong technical judgment with extensive technical leadership skills.
- Demonstrated capability of leading Verification & Validation Test Programs.
- Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.
- Solid knowledge of engineering first principles.
- 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.
- Familiarity with System Level Testing of software-based Medical Devices is a plus.
- Previous experience with National Instruments LabView, CVI, Test Stand, and/or Measurement Studio is a big plus.
- Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and quality experts.
- Demonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls is a plus.
- Experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
