Senior Test Engineer – Verification & Validation

Our medical device client is seeking a Senior Test Engineer to support the development of interventional products used in minimally invasive tumor treatment and targeted pain therapies. This role focuses on system-level verification and validation (V&V), test method development, and documentation supporting regulatory submissions.

You will partner with R&D, Systems Engineering, Quality, and cross-functional teams to define and execute robust testing strategies for systems incorporating mechanical, electrical, and software components.

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