Verification Validation Engineer

Company Description SARACA is a global engineering R&D services company partnering with more than 25 Fortune 500 clients across MedTech, Aerospace, Rail, Automotive, Semiconductor, Defense, and Farm industries. The company is ISO 13485 certified and has extensive experience in developing innovative medical devices, including embedded software, UI/UX, mechanical systems, and product testing. SARACA holds specialized expertise in IEC 62304, EU MDR, and scientific and clinical documentation for MedTech. With a technically strong team of 400+ engineers and management consultants operating across global locations, the organization focuses on solving complex business problems and delivering high-quality engineering outcomes. SARACA is an equal-opportunity employer that promotes a culture of innovation, learning, and customer-focused growth.Position: Verification (V&V) LeadLocation: Andover, MA (Onsite)Duration: Long-Term ContractBackground Check & Meet-and-Greet: MandatoryKey Responsibilities:• Own and maintain Verification Plans and Master V&V Plans for medical device products.• Define verification strategy aligned with IEC 62304 software lifecycle requirements.• Lead risk-based verification activities following ISO 14971.• Design and review verification protocols, test cases, and verification reports.• Establish and maintain requirements-to-test traceability.• Lead software, system, and subsystem verification activities.• Review defects, support root cause investigations, and oversee regression verification.• Produce audit-ready documentation for FDA, EU MDR, and notified body reviews.• Support DHF preparation, regulatory submissions, and compliance audits.• Mentor verification engineers and drive process improvements.Required Skills:• 8+ years of Medical Device Verification & Validation experience.• Strong knowledge of IEC 62304 and ISO 14971.• Experience with embedded systems, connected devices, or SaMD products.• Expertise in requirements traceability and design control processes.• Experience creating verification plans and test protocols.• FDA 21 CFR 820, ISO 13485, IEC 62366-1, and EU MDR knowledge.• Prior support for regulatory submissions and notified body audits.Preferred Background:Medical Device, Digital Health, Connected Devices, Diagnostic Systems, Infusion Pumps, Patient Monitoring Systems, Wearable Medical Devices, or SaMD products.If interested, please share your updated resume along with contact details, availability, work authorization, and expected rate.Best Regards,Recruitment Team