Test Engineer I
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Role details
Tech stack
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Job description
This position has the responsibility and authority to create and perform verification & validation activities for software and systems to ensure our Client’s cutting-edge medical products meet our user’s needs and our quality and reliability standards. This position requires application of technical expertise to determine and develop approaches to solve complex technical problems with ingenuity and creativity. Work is performed under general direction., * Test Planning & Execution: Generate plans, protocols, and reports for V&V testing of new or modified products. Design, develop, maintain, and execute both manual and automated tests.
- AI Tool Integration: Utilize AI tools to optimize workflows, write and debug test scripts, analyze code or requirement changes, and streamline reporting tasks.
- System & Equipment Management: Manage test schedules, tool/fixture/phantom design, and calibration. Set up test tracking systems and oversee external facility testing.
- Cross-Functional Collaboration: Participate in requirements, design, usability, risk assessment, and defect tracking phases while communicating findings to stakeholders.
- Maintenance & Improvement: Troubleshoot, debug, and support existing products while identifying process improvements.
- Compliance: Ensure all activities strictly comply with site EHS policies and Quality System regulations.
Requirements
- Regulated Environment Knowledge: Understanding of applicable AAMI, ISO, FDA, and EN standards (or relevant experience in a regulated industry).
- Software Lifecycle Proficiency: Solid working knowledge of software design, development, debugging, and testing practices.
- AI-Assisted Efficiency: Hands-on experience utilizing AI tools to write/debug test scripts, analyze code or requirement changes, and streamline documentation tasks.
Minimum Qualifications
- Education: Bachelor’s or Master’s degree in Engineering, Computer Science, or a related field.
- Experience:
- Bachelor’s Degree: 1-2+ years of relevant experience.
- Master’s Degree or higher: 0+ years of relevant experience.
- Communication: Excellent written and oral communication skills with a proven track record of working effectively in a team environment., * Domain & Testing: Experience with medical device testing, FDA Quality System Regulations (QSR), and 2+ years of direct application testing (Windows or Linux desktop environments).
- Automation & Tools: Experience designing automated test frameworks (GUI, integration, stress testing) using AI-assisted coding tools (e.g., GitHub Copilot, Cursor). Exposure to Cypress, Selenium, JavaScript, C++, Python, Perl, SQL, XML, or CI/CD pipelines.
- Development Methodology: Familiarity with Agile/iterative practices, project planning, and estimation. Passion for AI engineering is a major plus.
- Additional Skills: Machine shop experience and familiarity with statistical methods.
About the company
Our client is a global leader in medical technology that researches, designs, and manufactures healthcare devices.
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