Job Description

Join our dynamic team in Columbus, NE, where innovation meets manufacturing excellence. We are seeking a talented engineer to drive the design and implementation of cutting-edge assembly and packaging equipment. If you thrive in a collaborative environment and have a passion for optimizing manufacturing processes, this opportunity is for you!
Essential Job Functions:

• Design assembly and packaging equipment and create user requirements specifications (URS) that meet manufacturing standards.
• Develop and implement process designs for new equipment.
• Lead supplier relationships and external design teams for capital projects.
• Create/obtain detailed 3D models/2D drawings using CAD software.
• Optimize equipment designs for cost efficiency, changeover time, maintainability, and manufacturability.
• Perform engineering analyses to validate and optimize designs.
• Lead medical manufacturing process technology initiatives across all sites and products.
• Manage equipment development projects from requirements through implementation and site acceptance testing (SAT).
• Select vendors, manage procurement, and ensure successful equipment integration.
• Provide equipment and engineering cost inputs for business cases.
• Validate equipment designs meet safety and operational standards.
• Collaborate with suppliers on automation process optimization.
• Analyze process performance data from existing operations.
• Manage vendor contracts with procurement and legal teams.
• Develop innovative mechanical systems based on project requirements and industry standards.
• Create and maintain comprehensive design documentation including assembly instructions, bill of process, etc.
• Participate in design reviews and risk assessments.
• Build and maintain failure mode and effects analysis (FMEA).
• Collaborate on prototype development and testing.
• Coordinate with electrical and mechanical engineers for system integration.
• Provide technical expertise during production issues.
• Ensure compliance with Client quality policies, procedures, regulatory requirements, and industry standards.
• Design equipment for efficient operations to meet production targets and quality standards.
• Ensure equipment uptime and serviceability.
• Deliver projects on time and within budget.

Required Skills and Experience:

• 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.

Embark on a rewarding career in Columbus, NE, where your skills will contribute to innovative manufacturing solutions. Apply today and be a part of our success story!

Skills Required