Job Description

Job Title: Manufacturing Engineer Medical Device Industry

Job Type: Full-time

Location: Sumter, South Carolina, USA

Industry: Medical Equipment / Devices High-Speed Manufacturing

About the Role

A leading international manufacturer in the medical device industry is seeking a Manufacturing Engineer for its high-volume production site in Sumter, South Carolina . The facility specializes in automated assembly and packaging processes within a strictly regulated FDA and GMP environment. This role is focused on driving mechanical improvements, supporting capital projects, and enhancing operational efficiency.

Key Responsibilities

• Lead design and implementation of machine upgrades and mechanical improvements
• Manage capital equipment projects including planning, installation, and validation
• Troubleshoot chronic equipment and process issues, providing sustainable technical solutions
• Collaborate with cross-functional teams including production, maintenance, and external vendors
• Oversee and support documentation related to validations, SOPs, preventive maintenance, and engineering changes
• Supervise technicians and contractors during installations, modifications, or upgrades
• Apply Lean Manufacturing and Six Sigma principles to reduce waste, improve quality, and optimize performance

Must-Have Requirements

• Bachelors degree in Mechanical Engineering or closely related field
• Minimum 3 years of experience in a high-speed manufacturing environment , preferably in medical devices
• Practical experience with:
• Synchronous and asynchronous assembly systems
• Cam-operated equipment
• Pneumatic and servo-controlled machinery
• AutoCAD or equivalent CAD software
• Solid understanding of Lean Manufacturing
• Proven ability to troubleshoot and improve complex mechanical systems

Preferred Qualifications

• Six Sigma Green Belt or Black Belt certification
• Experience in FDA-regulated or GMP-compliant manufacturing settings
• Previous involvement in capital project execution and documentation
• Strong cross-functional communication and technical documentation skills

Workplace Details

• On-site role at a regulated medical device manufacturing facility
• Use of steel-toe, non-slip footwear required on production floor
• Jewelry, artificial nails, and visible dermal piercings not permitted in manufacturing zones
• Entire facility and outdoor premises are smoke-free

Why Apply?

Join a mission-driven company where your work directly supports global healthcare delivery. Youll be part of an experienced team driving engineering excellence in an advanced production environment. If you're passionate about mechanical systems, process optimization, and delivering impact at scalethis is your opportunity.

Apply now. Only qualified candidates will be contacted.

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