Sr Test Engineer

Intepros; Lafayette (CO); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Intepros is seeking a Senior Test Engineer to lead verification and validation activities for advanced medical device technologies. You will drive test method development, protocols, and regulatory documentation, and work across systems to ensure robust V&V strategies.

The role requires senior-level technical leadership, independent execution, and collaboration with cross-functional teams to deliver compliant verification across ex-vivo tissue and real-use scenarios.

Qualifications

• 6+ 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.

Responsibilities

• Develop verification plans for testing and validation.
• Create verification protocols with sample size justifications and acceptance criteria.
• Lead system-level verification activities for medical devices.
• Develop test methods and validation reports.
• Drive verification of design inputs including reliability and performance.
• Collaborate with cross-functional teams to implement V&V strategies.
• Produce regulatory submission-ready verification documentation.
• Support design validation with real end users and simulated-use environments.
• Assist in risk management activities and design reviews.
• Ensure designs are verified per applicable medical device standards.
• Conduct tests involving ex-vivo tissue and procedures.
• Analyze results and communicate findings to teams.
• Provide senior technical leadership to engineers and partners.
• Manage multiple priorities with execution discipline.

Skills

Verification & Validation Strategy

Test Method Development

Regulatory Documentation

Education

Bachelor’s degree in Engineering or scientific discipline

Advanced degree in Engineering or scientific discipline

Tools

Instron

Multimeters

Job description

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