Systems Engineer V&V

Role Overview

• 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 (DOORs, Helix, Jama).
• Collaborate with Systems Engineering in Systems Engineering COE to ensure that all requirements are testable
• 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
• Conduct and encourage frequent formal and informal communication with team members to ensure full engagement and efficient operation.
• 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)
• Develop new Test Cases and/or update existing Test Cases to match requirement updates and new understanding of system performance
• Perform dry-runs 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
• Perform verification testing following proscribed Test Cases for assigned projects.

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
• 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)
• Strong Analytical and Problem-Solving Skills
• 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
• Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS).

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs