Manufacturing Engineer

Hiring:

Job Title: Manufacturing Engineer

Location: Columbus, NE

Employment Type: W2 Only (No C2C)

Experience Required: 5+ Years

TECHNICAL SKILLS

Strong technical skills in project management and capital budgeting.
Experience leading end-to-end projects.
Demonstrated problem-solving and data analysis abilities
Risk analysis and statistical analysis expertise
Ability to manage multiple priorities and work independently.
 

Tooling design experience of assembly processes
Proficiency in SolidWorks
Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts Experience in an FDA regulated quality environment
 

Job Overview

Design assembly and packaging equipment and create URS documentation.
Develop and implement process designs for new manufacturing equipment.
Lead supplier relationships and manage external design teams for capital projects.
Create and review 3D models and 2D drawings using CAD software (SolidWorks).
Optimize equipment for cost efficiency, changeover time, maintainability, and manufacturability.
Conduct engineering analyses to validate and improve equipment designs.
Lead medical manufacturing process technology initiatives across multiple sites.
Manage equipment development projects from concept to SAT (Site Acceptance Testing).
Select vendors, manage procurement, and oversee equipment integration.
Provide engineering cost inputs for business cases and project planning.
Ensure equipment meets safety, regulatory, and operational standards.
Collaborate with suppliers to optimize automation processes.
Analyze performance data to drive process improvements.
Manage vendor contracts with procurement and legal teams.
Develop innovative mechanical systems and maintain technical documentation.
Participate in design reviews, risk assessments, and build FMEA.
Support prototype development, testing, and system integration.
Troubleshoot production issues and provide technical expertise.
Ensure compliance with BD quality, regulatory, and industry standards.
Design equipment to meet production targets while maintaining high uptime.
Deliver projects within timelines and budget requirements.
 

If you meet the above criteria and are open to W2 roles only, please share your updated resume at smita.s@tekprisminc.com