Medical Device Test Engineer – FDA/ISO 13485

Stark Pharma Solutions Inc; Stratford (CT); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Equal Opportunity Employer

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.

You will develop and execute tests, troubleshoot issues, and support regulated medical device systems. You will collaborate with R&D, Quality, Manufacturing, and Engineering to resolve defects and improve test methods, tools, and fixtures, while ensuring compliance with FDA and ISO 13485 requirements.

Qualifications

• 3+ years of test engineering experience in medical devices or regulated products.
• Hands-on integration and system testing experience.
• Experience developing and executing test protocols and test cases.
• Strong troubleshooting and root cause analysis skills.
• Knowledge of FDA and ISO 13485 requirements.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Perform integration and system testing of medical device systems and components.
• Develop, execute, and document test protocols and tests.
• Troubleshoot integration, performance, and functionality issues.
• Collaborate with R&D, Quality, Manufacturing, and Engineering teams to resolve defects.
• Support testing activities in compliance with FDA/ISO 13485 requirements.
• Analyze test results and provide clear feedback to engineers.
• Assist with root cause investigations and corrective actions.

Skills

Test Engineering

System testing

Medical devices

Troubleshooting

Test protocols

Data analysis

FDA ISO 13485

Cross-functional collaboration

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.

You will develop and execute tests, troubleshoot issues, and support regulated medical device systems. You will collaborate with R&D, Quality, Manufacturing, and Engineering to resolve defects and improve test methods, tools, and fixtures, while ensuring compliance with FDA and ISO 13485 requirements.