Operational Excellence Engineer

Principle Duties / Responsibilities

• Identify, execute, and sustain site-level hard and soft cost-saving initiatives supporting the Annual Cost Excellence (ACE) program
• Serve as the primary site-level execution resource for Operational Excellence initiatives
• Collaborate with engineering teams to review methods of manufacture and recommend practical improvements
• Develop, test, and introduce improved manufacturing processes into full-scale production environments
• Support and execute process validation and qualification activities (IQ, OQ, PQ, MSA)
• Provide hands-on technical support and training to production teams for machining and secondary processes
• Create, document, and maintain setup sheets, standard work, and work instructions
• Facilitate Kaizen events, Time Studies, Value Stream Mapping, and A3 problem-solving activities
• Serve as the site lead for Training Within Industry (TWI)
• Leverage 3D printing to design and deploy fixtures, tooling, and shop-floor aids
• Execute required EPICOR ERP transactions to support manufacturing and improvement activities
• Maintain site-level trackers, dashboards, and cost-savings documentation
• Adhere to Tyber Medical safety requirements and OSHA standards
• Work in compliance with cGMP, QMS requirements, SOPs, SWIs, and Good Documentation Practices (GDP)

Experience / Core Competencies

• Proven ability to work effectively in a production manufacturing environment
• Strong hands-on problem-solving mindset with a focus on execution
• Proven ability to establish and maintain effective working relationships across engineering, operations, and quality
• Strong understanding of shop-floor measurement tools, including calipers, micrometers, vision systems, and hard gages
• Working knowledge of Lean tools (5S, Gemba, Root Cause Analysis)
• Working knowledge of SOPs, SWIs, cGMP, GDP, and QMS requirements
• Working knowledge of ERP, production routings, and bill of materials
• Effective written and verbal communication skills
• Skilled in understanding and following verbal and written instructions
• Ability to spend approximately 80% of the workday on the manufacturing floor

Required / Preferred Education

• Bachelor’s degree in Mechanical, Manufacturing, or Industrial Engineering
• (Recent graduates encouraged to apply)
• Proficiency with SolidWorks, Microsoft Excel, Microsoft Word
• Lean Bronze certification or willingness to obtain

Experience

• Proven ability to operate CNC equipment
• Python programming experience
• Arduino or embedded systems exposure
• Automation or manufacturing systems integration experience