Manufacturing Process Engineer

Manufacturing Process Engineer

Department: Manufacturing Engineering

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Sr. Director Operations and Engineering

This 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.

• Design 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.

• Develop, 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.

• Lead 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.

• Support 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.

• Bachelor’s degree in Engineering (Manufacturing, Industrial, Biomedical, Mechanical, or related discipline) or equivalent experience.

• 1–3 years of experience in manufacturing, process engineering, industrial engineering, or operations.

• Experience in regulated industries (medical device, pharmaceutical, aerospace) preferred.