Systems Engineer – V&V

Systems Engineer – V&V

Requirements

• Bachelors’ Degree in Biomedical Engineering, Software Engineering, Computer Science, Mechanical, Electrical Engineering or a related field preferred.
• Minimum of 3 years’ experience testing medical devices in a multidisciplinary project team environment or advanced degree and 1+ years of experience.

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
• 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
• Provide technical consulting and mentoring in areas of expertise to early-career members of the Design Verification Test Team
• 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.
• Other duties within the scope of the Position Overview as assigned
• Ensure compliance with Insulet quality policies, procedures and practices
• Ensure compliance with all local, state and federal regulations, policies and procedures.

Preferred Qualifications

• Strong technical judgement with extensive technical leadership skills
• Experience with automation testing is a plus
• 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.
• 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
• 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), 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
• Experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.