Test Engineer
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Role details
Tech stack
Job description
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.
Requirements
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., 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.
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.
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