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Software V&V Engineer | Indianola , PA (Onsite) at Indianola, Washington, USA
Email: [email protected]
http://bit.ly/4ey8w48
https://jobs.nvoids.com/job_details.jsp?id=2006340&uid=

Title - Software V&V Engineer

Location - Indianola , PA (Onsite)

Job Description:

Top 3 must haves: (6-8 years exp)

1. Software V&V - V&V engineering and design controls in healthcare software development or other regulated software development

2. Test Architect experience in Software Verification in healthcare software development or other regulated software development

3. Maintain test automation framework for medical device products, Automating build creation and deployment, using Jenkins, AWS, and GitLab

4. AI/ML exposure/basics

JD:

Primary Function

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

Regards,

Adil Musawwir

E:

[email protected]

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Keywords: continuous integration continuous deployment artificial intelligence machine learning information technology Pennsylvania
Software V&V Engineer | Indianola , PA (Onsite)
[email protected]
http://bit.ly/4ey8w48
https://jobs.nvoids.com/job_details.jsp?id=2006340&uid=
[email protected]
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02:36 AM 12-Dec-24


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