Senior Test EngineerLocation: 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.
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