Test Engineer II

Real; Jacksonville (OR); Vor Ort; USD 85.000 - 120.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement savings plan

Life and disability insurance

Paid leave

Zusammenfassung

Specialist Staffing Group is seeking a Test Engineer II to support medical device software projects onsite. You will plan, execute, and document verification and validation activities to ensure software and test methods meet design specs, product requirements, and regulatory standards.

Collaborating with R&D, Quality, Manufacturing and Regulatory teams, you will develop protocols, perform statistical analyses, maintain traceability from requirements to tests, and prepare audit-ready reports for

Qualifikationen

• Bachelor's degree in a technical discipline or equivalent experience required.
• Experience in software testing, verification and validation, or test method validation within a regulated environment.
• Strong technical writing, attention to detail, and ability to apply statistical methods.

Aufgaben

• Plan, execute, and document verification and validation activities for software and test methods.
• Develop protocols and perform black-box/white-box testing for embedded systems.
• Maintain traceability among requirements, risks, test cases and results.

Kenntnisse

Verification

Validation

Test Method Validation

Software Testing

Statistical Analysis

Technical Writing

Requirements Traceability

Ausbildung

Bachelor's degree in a technical discipline

Jobbeschreibung

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

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law.

Eligibility may vary based on factors such as location and hire date and is subject to change.