Senior Manufacturing Engineer
? Location: Columbia, SC (Relocation Assistance Available)
? Schedule: Hybrid – 4 Days Onsite, 1 Day Remote (After Onboarding)
? Travel: Yearly travel to China & quarterly travel to Costa Rica
About the Role:
Are you a hands-on Senior Manufacturing Engineer looking to make a meaningful impact in the medical device industry? We’re seeking a dynamic problem solver to join our engineering team at our corporate headquarters in Columbia, SC. This is a highly visible role, directly supporting product commercialization and leading initiatives across process improvements, validations, and operational efficiencies.
In this position, you’ll play a pivotal role in sustained engineering efforts, process development, and equipment validation—while working closely with global manufacturing partners in China and Costa Rica. If you thrive in a fast-paced, highly regulated environment and enjoy wearing multiple hats, this is the opportunity for you!
What You’ll Do:
- Lead manufacturing engineering initiatives for product commercialization of durable and disposable medical devices.
- Drive process changes, equipment installations, and quality/cost improvements across operations.
- Manage change requests, analyze data from verification testing, and make recommendations for product safety and efficacy.
- Develop and execute IQ/OQ/PQ protocols for process and equipment validations.
- Ensure compliance with FDA 21 CFR 820.30, ISO 9001, and other regulatory standards.
- Work cross-functionally to write and update SOPs, support validations, and oversee hands-on manual processes as needed.
- Utilize SolidWorks or CAD software for tooling or machine design projects.
- Oversee multiple projects (10-12 per year), adapting quickly to changing priorities.
What You Bring:
? Education & Experience:
- Bachelor’s Degree in Mechanical, Electrical, or Industrial Engineering (or related field).
- 5+ years of experience in manufacturing/design engineering within a highly regulated industry (Medical Device, Pharma, Chemical, or Automotive).
- Lean Six Sigma certification (Green Belt or Yellow Belt preferred).
? Technical Skills & Knowledge:
- Experience with SPC (Statistical Process Control), IQ/OQ/PQ, and process validation.
- Proficiency in SolidWorks and/or CAD for design.
- Strong understanding of ISO 9001, process control methodologies, and regulatory compliance.
- Ability to use MS Project, MS Office Suite, and Visio for project management and documentation.
? Soft Skills & Work Environment:
- Excellent problem-solving, troubleshooting, and analytical skills.
- Ability to work independently or as part of a cross-functional team.
- Comfortable working in a fast-paced, evolving environment—managing multiple priorities.
- Strong communication and collaboration skills across internal teams and external partners.
Why Join Us?
? Global Impact – Work with international teams, including China & Costa Rica (travel opportunities!).
??? Innovative Industry – Contribute to cutting-edge medical device manufacturing.
? Career Growth – Join a team where you can grow, lead projects, and make a real impact.
? Diverse Responsibilities – Wear multiple hats and engage in a variety of projects.
