{"schemaVersion":"jobsearcher.job.v1","id":"d8d12df2eef24af2b938bd71","url":"https://jobsearcher.com/jobs/d8d12df2eef24af2b938bd71","canonicalUrl":"https://jobsearcher.com/jobs/d8d12df2eef24af2b938bd71","title":"Validation Engineer","description":"Job Title: Senior Verification & Validation (V&V) EngineerLocation: 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 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