Test Engineer II

About the role

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.

Responsibilities

• Develop and execute verification and validation protocols.
• Conduct black-box, white-box, integration, and system-level testing for embedded systems and medical device software.
• Maintain traceability among requirements, risks, test cases, and results.
• Analyze test outcomes, investigate anomalies, and prepare clear, technically sound reports.
• Collaborate with Research and Development, Quality, Manufacturing, and Regulatory teams to troubleshoot issues and deliver reliable, audit-ready results.
• Develop and execute Test Method Validation protocols.
• Perform statistical analyses such as Gauge R&R studies and analysis of variance.
• Define acceptance criteria and prepare comprehensive validation reports for audits and regulatory submissions.
• Identify sources of variation, recommend corrective actions, and align test methods with product design and manufacturing needs.
• Identify product and process risks, integrate risk controls into testing plans, and document risk assessments and mitigation actions.

Requirements

• Experience in software testing, verification and validation, or test method validation within a regulated environment is required.
• Strong technical writing, attention to detail, ability to apply statistical methods, interpret data, and communicate results.
• Analytical thinking, structured problem‑solving, and effective cross‑functional collaboration.

Qualifications

• Bachelor’s degree in software engineering, electrical engineering, biomedical engineering, computer science, or a related technical discipline, or equivalent relevant experience.

Skills

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

Benefits

• Health insurance
• Health savings accounts
• Retirement savings plans
• Life and disability insurance
• Paid leave (where required by applicable law)

Eligibility may vary based on location, hire date, and is subject to change.

Schedule

Full‑time, onsite.