Software Verification Lead

Primary Talent Partners has a Software Verification contract role for a client in Indianola, PA. This role is hybrid, must be local. Must be able to work on our W2, NO C2C and not require any current or future sponsorship.

Job Title: Digital Solutions - Software Verification Lead
Location: Indianola, PA
Type: Hybrid, onsite 3 days a week
Duration: 6 months
Primary Function
The Software Verification Lead is responsible for software verification and validation of our class II and higher regulated AI/Client SaMD products. The Software Verification Lead is 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 comprise 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 test.

TASKS AND RESPONSIBILITIES:
* Verification and Validation of software as a medical device including AI/Client 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 Client/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

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 2years experience in DevOps activities
* Technical writing ability - clear and concise writing easily understood by multiple audiences (testers, developers, auditors, peers, etc.)

Education Requirement:
* University degree (bachelor) in computer science or equivalent subjects

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

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

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