Digital Solutions-Software Verification Lead - TekWissen LLC
Indianola, PA
About the Job
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.
Job Title: Digital Solutions Software Verification Lead
Location: Indianola, PA, 15051
Duration: 6 Months
Job Type: Contract
Work Type: Hybrid
Job Description:
- 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 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/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 2years 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 Englis
- Knowledge of testing medical imaging algorithms and/or machine learning in the cloud
- Prior experience with scrum and test-driven development methods
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Source : TekWissen LLC
