Technology Partners is currently seeking a talented Software Verification Lead. Do you have 5 years of Test Architect experience in Software Verification within healthcare or regulated software environments? Let us help you make your next big career move a reality!
What You Will Be Doing:
The Software Verification Lead is responsible for leading and executing software verification and validation activities for our class II and higher regulated AI/ML SaMD products. This role requires a deep understanding of software development lifecycle, regulatory requirements, and test automation techniques.
Key Responsibilities:
- Verification and Validation of software as a medical device including AI/ML-based solutions.
- 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 medical device development, provided 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 and 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 a Center of Excellence (CoE) in the Software Assurance function
Required Skills & Experience:
- Education: University degree (bachelor) in computer science or equivalent subjects
- Experience:
- Minimum 8 years 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 5 years of Test Architect experience in Software Verification
- Minimum 5 years of V&V engineering and design controls
- Minimum 3 years of Test Automation experience and leading QA teams
- Minimum 2 years of DevOps experience
- Technical Skills:
- Strong technical skills in software testing, test automation, and software development methodologies
- Proficiency in scripting languages (Python, Perl)
- Knowledge of CI/CD tools (Jenkins, AWS, GitLab)
- Understanding of AI/ML concepts and their application in medical devices
- Soft Skills:
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Attention to detail and a strong work ethic
Desired Skills & Experience:
- Prior experience working in a regulated industry, particularly medical device software
- Knowledge of medical imaging algorithms and machine learning in the cloud
- Experience with scrum and test-driven development methods
Pay: $55.30 – $79.00 /hr.
We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to provide sponsorship at this time or accept candidates who would require a corp-to-corp agreement.
If this position sounds like you, WE SHOULD TALK!
We realize our people are our most valuable asset, that is why we offer the following benefits:
- Health, Dental, and Vision insurance
- 401(k) retirement plan
- Long and Short-Term disability
- Life insurance
- Direct deposit
- Referral program
Your better future is ready, and we want to put the right tools in your hands to get you there. Let's go!
Keywords: Software Verification Lead, Software Validation, Test Automation, CI/CD, DevOps, AI/ML, Medical Device, Regulatory Compliance, ISO 13485, IEC 62304, IEC 82304, FDA Design Controls
Looking for more opportunities with Technology Partners? Check out technologypartners.net/jobs!
Technology Partners is an Equal Opportunity Employer. Technology Partners does not discriminate on the basis of race, color, religion, sex, national origin, age, disability or any other characteristic protected by applicable state or federal civil rights laws.
All offers of employment at Technology Partners are contingent upon clear results of a thorough background check and drug screening that meet corresponding laws and regulations at the city, state and federal level.
Pay ranges are influenced by candidate qualifications, experience, and role specifics, with the actual rate determined considering skills, market conditions, and are subject to change by the employer; pay negotiations follow all state and federal legal guidelines.
