Medical Device Test Engineer - System Integration

Stark Pharma Solutions Inc; Windsor (CT); On-site; USD 85,000 - 105,000; Full time

Job summary

Stark Pharma Solutions Inc. in Connecticut is seeking a hands-on Test Engineer with experience in medical device testing, system integration, and validation.

The role focuses on developing and executing tests, troubleshooting issues, and supporting regulated medical device systems. You will collaborate with R&D, Quality, Manufacturing, and Engineering teams to drive test method improvements and ensure compliance with FDA and ISO 13485 requirements.

Qualifications

• 3+ years of hands-on test engineering in medical devices or regulated products.
• Experience with integration and system testing.
• Strong troubleshooting and root cause analysis skills.
• Knowledge of FDA and ISO 13485 requirements.

Responsibilities

• Perform integration and system testing of medical device systems.
• Develop, execute, and document test protocols and cases.
• Troubleshoot integration, performance, and functionality issues.
• Collaborate with R&D, Quality, Manufacturing, and Engineering to resolve defects.
• Support development and improvement of test methods, tools, and fixtures.
• Analyze test results and provide feedback to engineering.
• Ensure testing activities comply with FDA and ISO 13485.
• Assist with root cause investigations and corrective actions.

Skills

Test Engineering

Troubleshooting

Test Protocols

Data Analysis

Cross-functional Collaboration

Tools

Test tools

Job description

Stark Pharma Solutions Inc. in Connecticut is seeking a hands-on Test Engineer with experience in medical device testing, system integration, and validation.

The role focuses on developing and executing tests, troubleshooting issues, and supporting regulated medical device systems. You will collaborate with R&D, Quality, Manufacturing, and Engineering teams to drive test method improvements and ensure compliance with FDA and ISO 13485 requirements.