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Medical devices Test Engineer - Pittsburgh PA - Onsite at Pittsburgh, Pennsylvania, USA
Email: [email protected]
From:

Justin Davis,

GAC Solutions

[email protected]

Reply to: [email protected]

Hi,

I hope you're doing well!

Role: Senior Onsite Test Engineer- Medical devices

Work location: Pittsburgh PA - Onsite

6-12 months

JOB DESCRIPTION:

A. Requirement Analysis and Co-ordination:

Requirement gathering and analysis with Product owner, QA lead and Programming lead.

Convey the software testing requirements to the offshore team.

Co-ordinate the testing deliverables in between offshore team and Smith and Nephew Product owner, QA lead and Programming lead.

B. Managing End to End Product Verification and validation for Medical devices/Systems using manual and automation technics:

Provide estimation of the tasks based on various technics, and historical data.

Provide technical guidance to the team on testing requirements and provide optimal testing solutions.

Creation of test plan, test strategy, test scenarios, test cases (Protocol/Procedure) and test data as per software testing requirements.

Create and test clinical scenarios based on medical domain knowledge.

Maintain traceability matrix for test cases with requirements.

Review of test cases (protocols/procedure) created by offshore team.

Testing of Medical devices/Systems:

System preparation for testing. (Smith and Nephew devices) software installation, Complete System calibration of all models).

Execute system & software tests on Cori Arthroplasty Surgical System in compliance with the Smith & Nephews software development procedures.

Testing includes various levels of testing like functional, integration, regression, formal testing. Generating test documentation and reports.

Performance / Reliability testing of the Smith and Nephew devices

Formal Verification of protocols/procedures for Smith and Nephew devices by using automation and manual technic.

Perform verification of the Smith and Nephew devices for FDA regulatory standards.

Perform expert level testing based on medical domain knowledge and new trends in the industry.

Issues/Defects tracking and test reporting:

Defect raising and tracking for software failures in Jira.

Impact analysis and testing of defect fix, and new implementation.

Generate test summary reports for management review and Creation of periodic status reports on sprint and release testing efforts for metrics and defect triage generation.

E. Onshore-Offshore Coordination:

1.Coordinate with offshore teams to regularly connect and identify challenges.

2.Resolve any bottlenecks and provide timely response so team can proceed ahead.

3.Also Coordinating with Offshore on Issues having Hardware dependencies, coordinating Tasks requiring Smith & Nephew approvals, working with Smith & Nephew leads and managers on understanding and analysis of requirements and Field Defects and passing the technical information to Offshore.

Requirement Analysis and Co-ordination

Managing End to End Product Verification and validation for Medical devices/Systems using manual and automation technics

Testing of Medical devices/System

Issues/Defects tracking and test reporting

Onshore-Offshore Coordination" "Manual Test Development - Level of Proficiency 5

Manual, Automated Test Execution - Level of Proficiency 4

User Story, Requirement Analysis - Level of Proficiency 3

Defect reporting, re-verification - Level of Proficiency 2

Onshore-Offshore coordination - Level of Proficiency 1

Thanks,

Justin Davis

Sr Technical Recruiter

E:

[email protected]

Keywords: quality analyst Colorado Pennsylvania
Medical devices Test Engineer - Pittsburgh PA - Onsite
[email protected]
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Tue Aug 06 03:31:00 UTC 2024

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Location: Pittsburgh, Pennsylvania