Digital Solutions-Software Verification Lead

Job Description

Job Description

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.