Test Engineer III

Overview

The Test Engineer is responsible for planning, executing, and documenting verification and validation activities for regulated medical devices, with a primary focus on hardware and integrated systems. This role supports the full product development lifecycle, ensuring products meet design inputs, regulatory requirements, and applicable standards prior to market release.

The Test Engineer serves as a technical lead for test activities, working closely with Systems Engineering, Hardware Engineering, Software/Firmware teams, and Quality Assurance & Regulatory Affairs (QARA).

While initially focused on manual test execution, the role includes opportunities to introduce automation, improve test methods, and grow into a senior technical leadership position.

• Test Planning & Execution:
  Conduct pre-verification testing prior to formal verification and validation protocol execution.
• Develop, author, and execute formal verification and validation protocols for medical devices, including capital equipment, handheld devices, and sensors/disposables.
• Perform hands-on testing across multiple domains, including electrical safety, flow and pressure performance, gas delivery and sensing, end-product and simulator-based testing.
• Ensure testing is conducted in accordance with approved protocols, standards, and internal procedures.

• Author clear, complete, and compliant test documentation, including protocols, reports, and supporting evidence suitable for regulatory submissions.
• Ensure test activities align with applicable standards and regulations (e.g., ISO 13485, ISO 14971, IEC 60601, IEC 62304 where applicable).
• Support regulatory submissions by providing high-quality test documentation and traceable objective evidence.

• Work closely with Systems Engineering to ensure test coverage of system- and subsystem-level requirements and interfaces.
• Participate in design reviews, risk management activities, and testability reviews to influence product quality upstream.
• Collaborate with Hardware Engineering on defect investigation, root cause analysis, and verification of corrective actions.
• Cross-training with Software QA Team and assist with software-related testing as needed.
• Interface with QARA to ensure test strategies and documentation meet compliance.

• Act as a test lead on development projects, coordinating and guiding execution by technicians and junior engineers.
• Informally direct test resources during protocol execution while maintaining accountability for results and documentation quality.
• Utilize existing test fixtures and equipment; contribute to the specification, design, or improvement of new fixtures as needed.
• Maintain ownership of assigned lab spaces, ensuring equipment readiness, organization, and compliance with safety and quality requirements.
• Identify opportunities to improve test efficiency, robustness, and repeatability.
• Introduce automation where appropriate to supplement manual testing.
• Contribute to the evolution of test methods, templates, and best practices across the organization.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

None.

This role is primarily lab- and office-based, supporting the development and verification of regulated medical devices. The Test Engineer will spend significant time working hands-on with physical products, test equipment, and fixtures in a controlled laboratory environment, as well as time in an office setting for documentation, analysis, and cross-functional collaboration.

• Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
• Occasional lifting up to 50 lbs., occasional heavier lifting.
• Occasional pushing, pulling and handling of materials.

Very limited travel — less than 5%.

• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline).
• 3–6 years of experience in test, verification, or validation engineering within a regulated…