Senior Systems Engineer
hace 2 días
About Insulet
Insulet is a leading medical device company that has been improving the lives of hundreds of thousands of patients for over two decades. Our innovative technology enables our customers to enjoy simplicity, freedom, and healthier lives through the use of our Omnipod product platform.
Job Summary
We are seeking a highly motivated and performance-driven Senior Systems Engineer to join our expanding team. As a key member of our Systems Engineering COE, you will be responsible for leading Systems Engineering activities related to verification and validation of Insulet's products.
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 (e.g. IEC/AAMI/UL, etc.).
- 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.
Requirements
- 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.
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