Validation Engineer

Job Title: Senior Verification & Validation (V&V) Engineer

Location: Andover, MA (Hybrid)

Duration: 12

Job Type: W2

Important Duties:

• Perform verification and validation activities for medical device hardware, software, and integrated systems.
• Develop and execute V&V plans, test protocols, test methods, and reports under design controls.
• Maintain traceability between user needs, design requirements, risk controls, and test evidence.
• Perform software verification, including unit, integration, and system-level testing in accordance with IEC 62304.
• Develop test fixtures, validate test methods, and establish risk-based testing strategies.
• Coordinate external testing for electrical safety, EMC, biocompatibility, usability, and cybersecurity.
• Support design reviews, risk management, defect investigation, and resolution.
• Prepare V&V documentation to support FDA submissions and regulatory compliance.
• Collaborate with engineering, software development, quality, and regulatory teams.

Required Skills:

• Bachelor’s degree in Engineering or a related discipline.
• 3 years of medical device verification and validation experience.
• Hands-on experience developing and executing V&V protocols and reports.
• Knowledge of IEC 62304, ISO 13485, ISO 14971, IEC 60601, and 21 CFR Part 820/QMSR.
• Experience with requirements traceability, risk-based testing, and design controls.

Preferred Skills:

• Experience with connected medical devices, mobile applications, Bluetooth, or cloud-based systems.
• Familiarity with Jira, Jama, Helix, Python, or test automation tools.
• Experience supporting 510(k), De Novo, or PMA submissions.
• Knowledge of statistical sampling methods and quality management systems.