Job Description

Manufacturing Engineer

Location: Columbia, South Carolina

Join a dynamic and growing medical device manufacturer as a Manufacturing Engineer based in Columbia, SC. This critical role is focused on sustaining and improving the manufacturing processes for disposable medical devices. The ideal candidate is a hands-on engineer with process and equipment validation experience, a passion for continuous improvement, and a solid foundation in regulated environments.

Responsibilities

• Support and sustain daily manufacturing operations for disposable medical devices
• Drive process improvements to enhance product quality, reduce costs, and increase efficiency
• Execute and document process and equipment validations compliant with FDA, EU MDR, and other regulatory standards
• Collaborate with global manufacturing teams, contractors, and suppliers on engineering solutions and production support
• Manage change requests for specifications, equipment, manuals, and documentation
• Lead or assist in product transfers and process troubleshooting with domestic and international vendors
• Utilize SolidWorks (or similar) for machine and tooling design
• Analyze data using Excel and/or Minitab for process control and quality improvements
• Support cross-functional teams including Quality, Regulatory, and R&D
• Maintain clear and accurate project documentation using MS Office, Teams, and Outlook
• Provide guidance to junior engineers and interns as needed

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering or related field
• Minimum 1 year of engineering experience in a regulated manufacturing facility.
• Proficient with SolidWorks or equivalent 3D CAD software
• Knowledge of FDA 21 CFR 820.30, ISO, or similar regulatory standards
• Familiar with Lean Six Sigma principles; certification is a plus
• Experience with equipment installation, troubleshooting, and technical documentation
• Working knowledge of basic electrical systems and PLC troubleshooting
• Excellent written and verbal communication skills

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