Verification Validation Engineer

Company DescriptionSARACA is a global engineering R&D services leader, partnering with over 25 Fortune 500 companies in diverse industries such as MedTech, Aerospace, Rail, Automotive, and Defense. With ISO 13485 certification, SARACA specializes in innovative medical device design, embedded software, UI/UX, systems, and product testing. Our team of 400+ engineers and management consultants, guided by an accomplished leadership team, delivers world-class solutions globally. SARACA has unique expertise in IEC 62304 compliance, EU MDR, and advanced scientific writing for MedTech. As an equal-opportunity employer, SARACA fosters a culture of innovation, learning, and growth for its team and clients alike.Position: Mechanical Product Validation EngineerLocation: Cincinnati, OH (Onsite)Duration: 6+ Months ContractKey Requirements:• Bachelor's or Master's degree in Mechanical Engineering• Experience with Cleaning & Sterilization Validation for reusable medical devices• Strong background in Test Method Development and Validation• Product Quality and Product Validation experience• Hands-on experience with DFMEA, PFMEA, and Risk Management activities• Knowledge of GR&R, statistical analysis, and root cause investigations• Experience supporting Design Reviews and cross-functional product development teamsKey Responsibilities:• Develop and validate cleaning, sterilization, and reprocessing methods for reusable medical devices• Execute cleaning and sterilization feasibility studies and validation activities• Create and qualify test methods and perform GR&R studies• Conduct root cause analysis and provide technical recommendations• Support risk management activities including DFMEA, PFMEA, and hazard analysis• Collaborate with R&D, Quality, Regulatory, and external testing laboratories• Prepare validation protocols, reports, and technical documentationPreferred Background:• Medical Device Industry• Endoscopy, Surgical Instruments, or Reusable Medical Devices• FDA-regulated and ISO 13485 environmentsIf this opportunity aligns with your experience and interests, please reply with your updated resume and a convenient time to discuss further.