Senior Systems Verification and Validation Engineer
hace 1 mes
At Insulet Corporation, we are looking for a Senior Systems Verification and Validation Engineer to join our expanding team. This role is a technical expert responsible for leading Systems Engineering activities related to verification and validation of our products.
Job Summary:
The Systems Engineer V&V is a member of the Systems Engineering COE and reports to the Manager Systems Design Verification, Systems Engineering COE, Medical Devices R&D located at Insulet's Headquarters in Acton, MA.
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 60601-1, 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 procures
Requirements:
- 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
Preferred Skills and Competencies:
- Strong technical judgement 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.
- Sound knowledge of engineering first principals
- 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
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