Senior Test Engineer – Verification & Validation

Key Responsibilities: Lead system-level verification planning, execution, and documentation, including test method validation. Develop verification protocols with appropriate sample size justifications and clearly defined acceptance criteria. Verify design inputs for sterilized disposable instruments, including system compatibility, reliability, mechanical performance, and tissue performance. Develop test methods, validation plans, and validation reports. Perform device testing in ex-vivo tissue to evaluate performance during simulated minimally invasive procedures. Prepare clear, thorough engineering reports and verification evidence suitable for regulatory submissions. Support design validation with end users in real or simulated use environments. Participate in design reviews, risk management activities, and requirements traceability. Collaborate with manufacturing, quality, human factors, marketing, and regulatory teams to ensure testing aligns with applicable standards and procedures. Communicate test findings, analysis, and conclusions to cross-functional stakeholders. Provide senior-level technical guidance to internal engineers and external development partners. Independently manage testing activities after receiving high-level scope and constraints.

Required Qualifications: Bachelor’s degree in engineering or a scientific discipline with 6+ years of technical testing or engineering experience, or an advanced degree with 4+ years of relevant 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. Expertise in test method development and validation. Working knowledge of mechanical and electrical engineering fundamentals. Familiarity with mechanical and electrical test equipment, such as Instron systems and multimeters. Strong technical documentation, organization, prioritization, and communication skills. Ability to work independently and collaborate across engineering disciplines.

Preferred Qualifications: Experience in a regulated industry, such as medical devices, aerospace, or defense. Knowledge of IEC 60601, electrical safety testing, and electromagnetic compatibility (EMC) testing. Familiarity with Design for Reliability and Manufacturability (DRM) and Six Sigma practices. Experience tracing system design inputs to test results. Experience testing systems that integrate mechanical, electrical, and software elements. Experience owning systems engineering activities across the full V-model lifecycle. Core Areas of Focus Verification & Validation Strategy Leadership Test Method Development & Validation Test Execution & Regulatory Documentation