Validation Engineer
Job Title: Senior Verification & Validation (V&V) Engineer
Location: Andover, MA (Hybrid)
Duration: 12+Job Type: W2Important 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.