Design Verification Engineer

Overview

The Medical Device Design Verification Engineer develops and delivers FDA compliant design verification evidence that demonstrates functionality, performance, safety, and reliability. This includes translating product requirements into objective verification methods, authoring DV protocols with clear acceptance criteria and traceability, developing repeatable test setups and data-capture methods, executing DV testing, and producing DV reports suitable for regulatory submission. This role emphasizes hands-on test engineering, including instrumentation, fixturing, data acquisition, and automation, rather than primarily document review.

The Engineer partners with R and D, Quality, and Manufacturing to ensure DV evidence, test execution, and documentation are compliant with applicable standards and design controls. The DV engineer is part of an engineering team which is working in a regulated environment. A strong background in electronics testing, failure analysis, and FDA CFR 820 or ISO 13485 regulatory compliance is desired.

• Review and interpret product specifications, ensuring all hardware, electrical, mechanical, and firmware components align with functional, performance, safety, and reliability requirements.
• Own requirements-to-test evidence traceability:
  Maintain DV traceability linking product requirements, risk controls, protocols, and reports.
• Author FDA compliant DV protocols and reports:
  Define objective methods, sample size rationale and acceptance criteria. Clearly summarize results with appropriate write ups of observations and deviation handling.
• Develop repeatable test methods and test setups:
  Build and qualify test tooling, harnesses, fixtures, and data capture or automation needed for reproducible DV execution.
• Define data analysis approach:
  Apply appropriate statistics for variable data performance tests (repeatability, accuracy) and document the rationale.
• Ensure product requirements appropriately reflect applicable standards and regulatory requirements, including quality system, safety, and environmental compliance (e.g., FDA 21 CFR Part 820, ISO 13485, RoHS, REACH).
• Manage design verification tests, including thermal cycling, humidity, vibration, drop, EMI/EMC, ESD, and ingress protection (IP testing).
• Plan and execute accelerated life testing (ALT), highly accelerated life testing (HALT), and highly accelerated stress screening (HASS) to predict product reliability and lifespan.
• Design and execute test-to-failure programs to enhance product design and to anticipate customer worst case scenarios.
• Work with contract manufacturers to efficiently execute third-party testing and certification labs, ensuring adherence to compliance requirements.
• Contribute to the development process by executing dry run (pre-verification) testing to assess designs and identify issues early.
• Collaborate cross functionally with R&D, Manufacturing, and Quality to support failure analysis, drive corrective design improvements, and ensure all design improvements are properly tested prior to mass production.

• None

• BS degree in electrical engineering, mechanical engineering, biomedical engineering, or a related field.

• Minimum 5 years of experience in Design Verification of medical device hardware

• Proficiency in hardware validation techniques, and system-level testing.
• Experience authoring DV protocols and reports with clear acceptance criteria to measure the design against requirements, and requirements-to-test traceability.
• Hands-on DV test engineering: develop repeatable system-level test methods and setups and apply appropriate analysis for variable-data performance metrics (repeatability, accuracy) with risk-based sample size rationale.
• Experience developing custom data acquisition systems including use of modular DAQ hardware (e.g., TI-based DAQs), sensor instrumentation, and synchronized multi-channel data capture.
• Experience with oscilloscopes, power analyzers, spectrum analyzers, thermal imaging, and vibration test equipment.
• Knowledge of electromagnetic compatibility (EMC), electrostatic discharge…