Job ID: 50189
Location: Columbia, South Carolina
Employment Type: Direct Hire
Last Updated: 5 days ago
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 – regulated manufacturing facility preferred.
- 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
