Process Validation Engineer (Medical Device)

Process Validation EngineerLocation: 100% ONSITE - Waltham, MA (02451)Duration: 12 month contract - (extension potential)Pay: Negotiable depending on DIRECT related experience Up to $45 - $50/hrType: W2 contract ONLY - (C2C OR THIRD-PARTY arrangements will NOT be considered)Work Authorization: Must be currently located and authorized to work in the United States without sponsorship requirements.Job Summary and Required Experience: Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ).Demonstrated experience supporting both internally developed and externally sourced manufacturing processes within regulated environments.Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause investigation.Proficient in use of Minitab, or similar statistical software.Working knowledge of risk management and design control methodologies, including FMEA, control plans, and design transfer activities.Experience with complex medical device manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and/or injection molding preferred.Familiarity with electro-mechanical and capital equipment manufacturing processes preferred.Ability to troubleshoot complex manufacturing and process-related issues and implement effective corrective and preventive actions.Ability to read, understand, and create engineering drawings using common engineering software, including GD&T interpretation for tight-tolerance components.Ability to conduct complex statistical, geometric, and mathematical calculations.Demonstrated project and task management skills across multiple concurrent initiatives.Strong technical communication skills, including the ability to write and review protocols, reports, specifications, and technical documentation.*** Kelly does not expense relocation/interview costs. ***Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.