Manufacturing Process Engineer

Manufacturing Process EngineerDepartment: Manufacturing EngineeringEmployment Type: Full TimeLocation: Gainesville, FLReporting To: Sr. Director Operations and EngineeringDescriptionThis role is accountable for designing, stabilizing, and continuously improving end-to-end manufacturing process flow. The Manufacturing Process Engineer focuses on how work moves through the system - people, materials, information, and controls - to ensure predictable, compliant, and efficient production of orthopedic medical devices.Key ResponsibilitiesProcess Design & Flow OptimizationDesign and maintain end-to-end manufacturing process flows across operations, including handoffs between workstations, inspection points, and downstream processes.Analyze throughput, constraints, and work balance to improve Safety, Quality, Delivery, and Cost (SQDC) outcomes.Develop future-state process flows and lead implementation of changes in partnership with Operations and Quality.Standard Work & Operational DisciplineDevelop, implement, and sustain Operator Standard Work (OSW) and process-level documentation that defines the expected method of work.Establish visual management and tiered performance metrics to enable daily management and rapid problem identification.Ensure process changes are effectively transferred to production through training alignment and documentation updates.Problem Solving & Continuous ImprovementLead structured problem-solving activities for process-related issues using data-driven root cause analysis.Facilitate continuous improvement activities focused on flow, stability, and waste reduction rather than tooling optimization.Support corrective and preventive actions related to process deviations and nonconformances.Validation & ComplianceSupport execution of process and equipment qualification and validation activities (IQ/OQ/PQ) from a process-flow and risk perspective.Ensure manufacturing processes comply with the Quality System and applicable regulatory requirements.Maintain controlled process documentation through change management systems.Skills Knowledge and ExpertiseEducation* Bachelor's degree in Engineering (Manufacturing, Industrial, Biomedical, Mechanical, or related discipline) or equivalent experience.Experience* 1-3 years of experience in manufacturing, process engineering, industrial engineering, or operations.Skills & Knowledge* Experience in regulated industries (medical device, pharmaceutical, aerospace) preferred.