Lead Automation Tester

Lead Automation Tester
Indianola, PA (onsite)

The Software Verification Lead is responsible for software verification and validation of our class II and higher regulated AI/ML SaMD products. The Software Verification Lead provides guidance and support for non-senior and external Quality Assurance Engineers as well as Leads and is responsible for process improvements in the software verification area as well as in the software requirement area. Software verification comprises but is not limited to engineering of software verification and validation, requirement engineering, development of test strategy, deploy and maintain CI/CD (DevOps) pipelines along with execution and reporting of tests.

Responsibilities-
• Verification and Validation of software as a medical device including AI/ML based solution.
• Architect test strategy, development and execution of manual and/or automated software verification protocols, including
• Requirement analysis and review
• Architect test strategy
• Design and development of test scenarios
• Authoring and review of test cases and protocols
• Performing execution of test cases
• Analyzing results, tracking discrepancies, and writing reports
• Deploy and maintain CI/CD (DevOps) pipelines, including:
• Developing and maintaining Continuous Integration Deployment Testing infrastructure to accelerate product development cycle time
• Maintain test automation framework for medical device products
• Automating build creation and deployment, using Jenkins, AWS, and GitLab
• Scripting using Python, Perl, and other scripting languages
• Lead and manage verification and validation of complex AI software projects with cross functional teams distributed across multiple geographies under new product development (NPD) and/or Life Cycle Engineering (LCE) initiatives of ML/AI based Software as a medical device development, provide guidance and consulting to the team on technical and process issues, review deliverables of the team
• Fulfilling activities to comply with the project deliverables outlined in the Design and Development Plans and Design Control Procedures, as applicable.
• Compliance with standard operating procedures for medical device development, including compliance with ISO 13485, IEC 62304, IEC 82304 and FDA Design Controls CFR 820.30
• Individual contribution as well as managed activities involving verification planning, test execution and software integration.
• Critical analysis of technical situations to identify problems, and work with the cross-functional team in resolving the problems.
• Collaborating within cross-functional teams (technical lead, product manager, risk manager, software engineer, medical & clinical affairs and regulatory affairs) across multiple geographies to convey problems, opportunities, solutions, and results in software development activities
• Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function
Education Requirement:
• University degree (bachelor) in computer science or equivalent subjects
Skills & Competency Requirements:
• Minimum of 8 years or more of relevant work experience in software testing, software engineering, requirement engineering and/or risk engineering in healthcare software development or other regulated software development
• Minimum of 5 years or more of Test Architect experience in Software Verification in healthcare software development or other regulated software development
• Minimum of 5 years of V&V engineering and design controls in healthcare software development or other regulated software development
• Minimum of 3 years of Test Automation experience in Software Verification and Leading QA teams
• Minimum of 2 years experience in DevOps activities
• Technical writing ability - clear and concise writing easily understood by multiple audiences (testers, developers, auditors, peers, etc.)
Preferences:
• Prior experience of working in Quality Systems Regulations with knowledge of documentation systems (i.e., Verification/Validation Protocols, SOPs) required of a business in the regulated industry
• Prior experience designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485, IEC 62304, IEC 82304 and FDA Design Controls CFR 820.30
• Distinct conceptual and result-oriented thinking as well as customer orientation, high flexibility, and resilience
• Work experience in an international environment and fluent language skills (spoken and written) in English
• Knowledge of testing medical imaging algorithms and/or machine learning in the cloud
• Prior experience with scrum and test-driven development methods