Test Engineer II

A Test Engineer II is sought to support medical device software projects, focusing on verification, validation, and test method validation activities. This full-time, onsite role involves planning, executing, and documenting testing processes to ensure software and associated test methods meet design specifications, product requirements, risk controls, and regulatory standards.

Key responsibilities include developing and executing verification and validation protocols, conducting black-box, white-box, integration, and system-level testing for embedded systems and medical device software, and maintaining traceability among requirements, risks, test cases, and results. The engineer will analyze test outcomes, investigate anomalies, and prepare clear, technically sound reports. Collaboration with Research and Development, Quality, Manufacturing, and Regulatory teams is essential to troubleshoot issues and deliver reliable, audit-ready results.

The role also involves developing and executing Test Method Validation protocols, performing statistical analyses such as Gauge R&R studies and analysis of variance, defining acceptance criteria, and preparing comprehensive validation reports for audits and regulatory submissions. The engineer will identify sources of variation, recommend corrective actions, and align test methods with product design and manufacturing needs.

Risk management is a key aspect, requiring the identification of product and process risks, integration of risk controls into testing plans, and documentation of risk assessments and mitigation actions.

Candidates should hold a bachelor’s degree in software engineering, electrical engineering, biomedical engineering, computer science, or a related technical discipline, or possess equivalent relevant experience. Experience in software testing, verification and validation, or test method validation within a regulated environment is required. Strong technical writing, attention to detail, and the ability to apply statistical methods, interpret data, and communicate results are essential. The role demands analytical thinking, structured problem-solving, and effective cross-functional collaboration.

Must-Have Skills: Verification, Validation, Test Method Validation, Software Testing, Statistical Analysis, Technical Writing, Requirements Traceability

Nice-to-Have Skills: Defect Management, Design Controls, Risk Assessment, Cross-functional Collaboration, Regulatory Compliance, Analytical Thinking, Problem-solving, Continuous Improvement