Test Engineer

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

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Test Engineer
Location: Connecticut
Duration: Long Term

Job Overview

We are seeking a hands-on Test Engineer with experience in medical device testing, system integration, and validation. The role will focus on developing and executing tests, troubleshooting issues, and supporting regulated medical device systems.

Key Responsibilities

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

Required Qualifications

• 3+ years of relevant Test Engineering experience.
• Hands-on experience with integration and system testing.
• Experience testing medical devices or regulated products.
• Strong troubleshooting and root cause analysis skills.
• Experience developing and executing test protocols and test cases.
• Experience with test methods, tools, and fixtures.
• Strong data analysis and technical reporting skills.
• Knowledge of FDA and ISO 13485 requirements.
• Strong communication and cross-functional collaboration skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds