Test Engineer

TALENT Software Services; Waukesha (WI); On-site; USD 85,000 - 120,000; Full time

Job summary

TALENT Software Services is seeking a skilled QA Specialist to perform manual testing and V&V for invasive cardiology medical devices in a regulated environment. The role focuses on ensuring product quality and FDA/QMS/GxP compliance during releases, with defect tracking and validation activities throughout the lifecycle.

The candidate should have 3–8+ years of experience in medical device or healthcare product testing, and familiarity with cardiology workflows is preferred.

Qualifications

• Manual testing experience in medical devices or healthcare.
• Understanding of cardiology workflows (preferred).
• Knowledge of V&V, CSV, and regulatory compliance.

Responsibilities

• Design and execute manual test cases and scenarios
• Perform functional, integration, and system testing
• Conduct verification & validation (V&V) for product releases
• Log, track, and validate defects
• Prepare test plans, reports, and validation documentation
• Ensure compliance with FDA, QMS, and GxP standards

Skills

Manual testing

Cardiology workflows

V&V, CSV, regulatory compliance

Job description

Role Overview:

Responsible for manual testing and verification & validation (V&V) of invasive cardiology medical devices, ensuring product quality and compliance with regulatory standards.

Role Overview:

Responsible for manual testing and verification & validation (V&V) of invasive cardiology medical devices, ensuring product quality and compliance with regulatory standards.

Key Responsibilities:

• Design and execute manual test cases and scenarios
• Perform functional, integration, and system testing
• Conduct verification & validation (V&V) for product releases
• Log, track, and validate defects
• Prepare test plans, reports, and validation documentation
• Ensure compliance with FDA, QMS, and GxP standards

Skills:

• Manual testing experience in medical devices or healthcare
• Understanding of cardiology workflows (preferred)
• Knowledge of V&V, CSV, and regulatory compliance

Experience:

• 3–8+ years in medical device or healthcare product testing