Manufacturing Engineer
Manufacturing Engineer
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Salary Not Disclosed
1 Vacancy
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 youre passionate about mechanical systems process optimization and delivering impact at scalethis is your opportunity.
Apply now. Only qualified candidates will be contacted.
Benefits
- Comprehensive health benefits (medical dental vision)
- Annual performance bonus opportunity
- Long-term incentive programs
- 401(k) with company match
- Generous paid time off and recognized holidays
- Relocation assistance (for qualified non-local candidates)
- Structured onboarding and career development opportunities
Employment Type
Full Time
