Process Development Engineer

Location: Huntersville, North CarolinaType: Direct HireJob #11632Salary: $90000Location Type: On-SiteResponsible for developing, validating, and sustaining manufacturing processes and equipment used in medical device production. This role ensures products can be reliably transitioned from design to scalable production through process development, tooling/fixture design, validation (IQ/OQ/PQ), and cross-functional support. The engineer will also support production transfers, supplier manufacturing, and process improvement activities while ensuring compliance with FDA and ISO requirements.Required ExperienceBachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related field3+ years of experience in medical device or pharmaceutical manufacturingHands-on experience with process development, process flow design, and manufacturing documentationExperience executing or supporting validation activities (IQ/OQ/PQ)Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirementsExperience developing or supporting process FMEAs and risk management activitiesAbility to create and maintain work instructions, process documentation, and technical reportsExperience supporting production troubleshooting and manufacturing issue resolutionProficiency in Microsoft Office and strong documentation skillsPreferred ExperienceExperience with production transfers from R&D to manufacturingExposure to fixture/tooling design and manufacturing equipment developmentExperience with CAD tools (SolidWorks, Solid Edge, or similar)Familiarity with Lean Manufacturing principles and continuous improvementExperience working with suppliers or contract manufacturersKnowledge of process capability analysis and validation protocolsStrong cross-functional collaboration with Quality, R&D, and Operations teams #J-18808-Ljbffr