Systems Validation Engineer

The Cervantes Group; Acton (MA); On-site; USD 85,000 - 115,000; Full time

Job summary

A leading company in the medical device industry is seeking a Systems Validation Engineer to lead verification and validation activities for their products. The role involves developing test strategies, collaborating with engineering teams, and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in software and system testing, along with excellent communication skills and experience in an Agile environment.

Qualifications

• Minimum of 5 years’ experience in software testing, system testing, and product testing.
• At least 2 years of experience specifically in software, system, and product testing.

Responsibilities

• Lead Systems Engineering activities related to Verification and Validation of medical device products.
• Develop and maintain test strategies, protocols, and reports for system verification.
• Mentor junior team members on statistical analysis and risk-based test coverage.

Skills

Communication

Agile

Cross-functional Communication

Education

Bachelor’s degree

Tools

Helix

Jama

Polarion

Job description

Job Description

The Systems Validation Engineer will be a technical expert responsible for leading Systems Engineering activities related to Verification and Validation of medical device products. Develop, review, implement, and maintain test strategies, test protocols, test cases, test reports, and traceability matrices for system verification, ensuring hardware and software components are verified for release. This person will report defects and issues to management and engineering teams, working closely with the System Automation Test team to optimize test coverage and execution strategies.

Responsibilities:

1. Collaborate with Systems Engineering to ensure requirements are testable and appropriately leveled for verification with component test teams (Hardware/Software).
2. Provide technical leadership for the System Design Verification team in preparation for product releases and lead initiatives to improve processes and tools related to Design Verification according to System Engineering COE objectives.
3. Coordinate with project managers, system engineers, and technical leads to plan and execute project goals, working closely with the System Automation Test team to optimize test coverage and execution.
4. Manage and track product configurations, including hardware, software, and firmware versions, and assess impacts of configuration changes on System Design Verification.
5. Lead the development and execution of system integration, verification, and regression plans.
6. Develop, review, implement, and maintain test strategies, protocols, cases, reports, and traceability matrices for system verification.
7. Conduct Verification and Validation activities for new product development and sustaining products.
8. Report defects during testing and assist in root cause analysis.
9. Perform impact analysis and provide effort estimates.
10. Define, track, and report KPIs related to product verification and quality.
11. Mentor junior team members on topics such as sample size justification, statistical analysis, and risk-based test coverage optimization.
12. Ensure compliance with regulatory standards and quality policies, procedures, and practices.

Required Skills/Experience:

1. Bachelor’s degree required.
2. Excellent verbal and written communication skills in English.
3. Minimum of 5 years’ experience in software testing, system testing, and product testing within multidisciplinary project teams.
4. At least 2 years of experience specifically in software, system, and product testing.
5. Familiarity with medical device system-level testing.
6. Experience working in an Agile software development environment.
7. Strong cross-functional communication skills.

Preferred:

• Experience with requirements management tools (e.g., Helix, Jama, Polarion), quality management systems, test case management, and defect management tools.
• Experience with automated testing is a plus.