Systems Validation Engineer

ZipRecruiter; Acton (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in medical devices is seeking a Systems Validation Engineer. This role involves leading verification and validation activities, developing test strategies, and ensuring compliance with regulatory standards. Candidates should have strong communication skills and experience in software testing. Join a dynamic team dedicated to improving product quality and processes.

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 development and execution of system integration, verification, and regression plans.
• Collaborate with Systems Engineering to ensure requirements are testable.
• Report defects found during testing and assist in root cause analysis.

Skills

Communication

Collaboration

Agile

Statistical Analysis

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 while hardware and software components are verified for release. This person will report defects and issues to upper management and engineering teams, working closely with the System Automation Test team to optimize test coverage and execution strategies.

Responsibilities:

• Collaborate with Systems Engineering to ensure requirements are testable and appropriately leveled for verification with component-level test teams (Hardware/Software).
• 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.
• 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 strategies.
• Manage and track product configurations, including hardware, software, and firmware versions, and assess impacts due to configuration changes on System Design Verification.
• Lead the development and execution of system integration, verification, and regression plans.
• Develop, review, implement, and maintain test strategies, protocols, cases, reports, and traceability matrices for system verification.
• Deliver Verification and Validation activities for new product development and sustaining products.
• Report defects found during testing and assist in root cause analysis.
• Drive impact analysis and effort estimation.
• Define, track, and report KPIs for product verification and quality.
• Mentor junior team members on topics such as sample size justification, statistical analysis, and risk-based test coverage optimization.
• Ensure compliance with regulatory standards and quality policies, procedures, and practices.

Required Skills/Experience:

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

Additional Skills:

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