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? Were 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 validationwhile 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 Youll 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 :
Bachelors 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.
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