Job Location : all cities,AL, USA
Contract (5 months 29 days)
Published 8 months ago
CLOSED
Verification & Validation
AL/ML Products
Python Programming
Job Summary
Join our Radiology Software Assurance & Operations Team as a Digital Solutions Software Verification Lead. In this role, you will be pivotal in ensuring the software verification and validation of our class II and higher regulated AI/ML SaMD products. You will lead the engineering of software verification and validation processes, guide Quality Assurance Engineers, and drive process improvements in software verification and requirement areas.
Responsibilities
- Verify and validate software as a medical device, including AI/ML-based solutions.
- Architect test strategy, develop and execute manual and/or automated software verification protocols.
- Design test scenarios, author test cases, execute tests, analyze results, track discrepancies, and write reports.
- Deploy and maintain CI/CD (DevOps) pipelines for product development acceleration.
- Lead complex AI software projects with cross-functional teams under new product development initiatives.
- Ensure compliance with regulatory standards such as ISO 13485, IEC 62304, IEC 82304, and FDA Design Controls CFR 820.30.
- Contribute to verification planning, test execution, software integration, and problem resolution within the team.
- Collaborate with cross-functional teams across geographies to convey problems, solutions, and results in software development activities.
Skills
- Minimum 8 years of relevant work experience in healthcare or regulated software development.
- Minimum 5 years of Test Architect experience in healthcare or regulated software development.
- Minimum 5 years of V&V engineering experience in healthcare or regulated software development.
- Minimum 3 years of Test Automation experience in Software Verification and Leading QA teams.
- Minimum 2 years of DevOps activities experience.
- Strong technical writing skills for various audiences.
Qualifications
- University degree (bachelor) in computer science or equivalent subjects.
This is an exciting opportunity to lead cutting-edge AI/ML SaMD product verification efforts while collaborating with global teams on innovative projects. Join us to make a meaningful impact on healthcare technology advancement.
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