Sr Test Engineer

The Sr Test Engineer will support system verification and validation (V&V) for Interventional products within an R&D environment. The role leads verification planning, test method development and validation, execution, and regulatory-ready documentation while partnering with Systems Engineering, Design, Quality, Manufacturing, Marketing, Human Factors, and Regulatory teams. The ideal candidate can work independently from high-level scope and constraints and provide senior-level technical leadership throughout the product development cycle. Top 3 Technical Skills

• Verification & Validation Strategy Leadership
• Test Method Development & Validation
• Execution Discipline & Regulatory Documentation, * Develop comprehensive verification testing plans, including test method validation.
• Create verification protocols with sample-size justifications and acceptance criteria.
• Lead design-input verification for sterilized disposable instruments, including system compatibility, reliability, mechanical performance, and tissue performance.
• Develop test methods, test method validation plans, and validation reports.
• Build and document verification evidence through regulatory submission-ready engineering reports.
• Support design validation of user needs with real end-users in real or simulated-use environments.
• Support design reviews and risk management activities.
• Partner with Systems, Mechanical, Electrical, Design Quality, and laboratory teams throughout V&V activities.
• Work with Manufacturing, Quality, Marketing, Human Factors, and Regulatory teams to ensure designs are verified in compliance with medical device standards.
• Execute minimally invasive therapy procedures and product testing in soft tissue according to applicable standards and internal procedures.
• Analyze and communicate test findings, conclusions, and recommendations to cross-functional teams.
• Provide senior-level technical leadership to internal engineers and external development partners.
• Support system-level validation planning, execution, and documentation.

• Bachelor’s degree in Engineering or a scientific discipline with 6+ years of technical testing or engineering experience, OR
• Advanced degree in Engineering or a scientific discipline with 4+ years of technical testing or engineering experience.
• Experience leading system-level verification planning, execution, and documentation.
• Experience supporting system-level validation planning, execution, and documentation.
• Experience testing devices in ex-vivo tissue.
• Basic knowledge of mechanical and electrical engineering fundamentals.
• Basic knowledge of mechanical and electrical test equipment, such as Instron and multimeters.
• Ability to work independently and effectively within a cross-functional team environment.
• Strong organizational, prioritization, and communication skills.

Preferred Qualifications

• Experience working in a regulated industry, such as medical, aerospace, or defense.
• Knowledge of IEC 60601 testing standards.
• Knowledge of electrical safety and EMC testing.
• Familiarity with Design for Reliability and Manufacturability (DRM) and Six Sigma practices.
• Experience tracing system design inputs through test results.
• Experience working with systems containing mechanical, electrical, and software elements.
• Experience owning systems-engineering execution across the full V-model lifecycle., * Verification & Validation (V&V)
• Test Method Development
• Test Method Validation
• System-Level Testing
• Regulatory Documentation
• Design Verification & Validation
• Risk Management
• Medical Device Testing
• Mechanical & Electrical Testing
• Ex-Vivo Tissue Testing
• IEC 60601
• EMC & Electrical Safety Testing
• Six Sigma / DRM
• Cross-Functional Leadership
• Technical Reporting

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• Lafayette, LA

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About Cogent Infotech Cogent Infotech is a technology and talent solutions company headquartered in Pittsburgh, PA. We support clients across commercial, federal, state, and local…