Sr Test Engineer

Senior Test Engineer

Location: Hybrid – 4 days onsite, 1 day remote

Schedule: 40 hours per week

Interview Timeline: ASAP

We are actively seeking a Senior Test Engineer to support the development and testing of innovative medical device technologies. This role will provide senior-level technical leadership across system verification and validation (V&V), test method development, execution, and regulatory documentation.

The ideal candidate will have strong experience developing and executing V&V strategies within a regulated environment, along with the ability to independently drive testing activities from high-level requirements through final documentation.

Top 3 Technical Skills

• Verification & Validation Strategy Leadership
• Test Method Development & Validation
• Execution Discipline & Regulatory Documentation
  
  

Key Responsibilities

• Develop comprehensive plans for verification testing, including test method validation.
• Create verification protocols, including sample size justifications and acceptance criteria.
• Lead system-level verification activities for complex medical device products.
• Develop test methods, test method validation plans, and test method validation reports.
• Drive verification of design inputs, including system compatibility, reliability, mechanical performance, and tissue performance.
• Partner with Systems, Mechanical, Electrical, Quality, and other engineering teams to develop robust and efficient V&V strategies.
• Develop clear, regulatory submission-ready engineering documentation and verification reports.
• Support design validation activities involving real end users and simulated-use environments.
• Support design reviews and risk management activities.
• Partner with Manufacturing, Quality, Marketing, Human Factors, and Regulatory teams to ensure designs are verified in accordance with applicable medical device standards.
• Perform testing involving ex-vivo tissue and minimally invasive therapy procedures in accordance with applicable standards and internal procedures.
• Analyze test results and effectively communicate findings, conclusions, and recommendations to cross-functional teams.
• Provide senior-level technical leadership to internal engineers and external development partners.
• Work independently while managing multiple priorities and maintaining strong execution discipline.
  
  

Required Qualifications

• 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.
• Working knowledge of mechanical and electrical engineering fundamentals.
• Working knowledge of mechanical and electrical test equipment, such as Instron, multimeters, and similar equipment.
• Demonstrated ability to work independently and effectively within a cross-functional team.
• Strong organizational, prioritization, analytical, and communication skills.
  
  

Preferred Qualifications

• Experience working in a regulated industry, such as medical devices, 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 verification testing and results.
• Experience working with systems incorporating mechanical, electrical, and software components.
• Experience owning or leading systems engineering execution across the full V-model lifecycle.
  
  

DR2