Process Engineer

Location: Sumter, SC

Type: Full-Time Onsite

The Process Engineer reports to the Manufacturing Unit Technical Leader and will drive engineering process improvements, capital equipment upgrades, efficiency gains, and cost reduction initiatives. This role supports troubleshooting, equipment design improvements, vendor coordination, and provides technical leadership on continuous improvement and production optimization.

• Lead and support capital equipment projects, including design, installation, testing, and validation
• Troubleshoot mechanical, pneumatic, cam‑driven, and hydraulic systems
• Develop engineering specifications, drawings, and calculations
• Support plant operations by identifying issues and implementing corrective actions
• Manage projects of moderate to large scope, including vendor selection and oversight
• Prepare capital expenditure requests; track budget and timelines
• Ensure compliance with safety standards and regulatory requirements
• Maintain documentation: SOPs, change notifications, validation, PM schedules, and spare parts
• Provide training and direction to internal support personnel
• Drive efficiency, quality, waste reduction, and process improvement initiatives
• Coordinate across R&D, vendors, maintenance, and production
• Evaluate in‑house vs. outsourced fabrication options

• Bachelor's degree in Mechanical, Chemical, or Bioengineering preferred
• All experience levels considered (compensation aligns with experience)
• Strong mechanical design and troubleshooting capability
• Hands‑on experience with manufacturing equipment and capital project execution
• Ability to manage multiple projects simultaneously
• Understanding of engineering safety and compliance standards

• Experience in medical device or regulated manufacturing
• Cam‑driven equipment troubleshooting
• Pneumatic & hydraulic systems knowledge
• Experience with equipment validations and documentation
• Vendor and contractor management
• Cost reduction & process improvement experience

• Steel toe shoes required
• No jewelry, false eyelashes, or press‑on nails allowed in production areas
• Must work onsite (minimum 4 days per week)
• Smoke‑free campus

• Strong communication & leadership
• Ability to collaborate cross‑functionally
• Root cause analysis & problem‑solving strength
• Time management and prioritization
• Project ownership and accountability