Process Engineer
On-siteMason, Ohio, United States
Job Summary
Own product assembly line technical performance by troubleshooting issues, resolving non-conformances, and leading root cause investigations and CAPAs. Drive continuous improvement through value stream mapping, 5S, Kaizen events, and lean principles to optimize manufacturing processes and eliminate bottlenecks. Collaborate with cross-functional engineering teams to address product line issues, review component tolerances, and implement design for assembly opportunities. Execute process qualification strategies, maintain FMEAs, and write detailed protocols while documenting all work in compliance with quality systems. Analyze production data to identify inefficiencies, reduce costs, and improve yield, consistency, and capacity across daily operations.
Required Qualifications
- Bachelor's degree in engineering (mechanical, industrial, or related field)
- 3 + years of relevant experience
- Demonstrated Mechanical and/or Process Engineering ability
- Solid understanding of external standards, design controls, quality controls, manufacturing methods
- Demonstrates the ability to plan and track tasks to align with project plan and team objectives
- Demonstrates excellent written and oral communication skills
- Demonstrates excellent ability to work on and influence cross functional teams
- Demonstrated ability with data analysis, problem-solving, and troubleshooting
- Capable of prioritizing tasks and provide a timely schedule of completion
- Ability to travel 5%
- Ability to regularly walk, sit, or stand as required
- Ability to occasionally bend and push/pull
- Ability to regularly lift up to 10 pounds, occasionally lift over 50 pounds
- Ability to pass pre-employment drug screen and background check
Desired Qualifications
- Medical device industry experience
- Lean Six Sigma certification (Green Belt (or) Black Belt)
- Demonstrated lean manufacturing process implementation experience
- Proficiency in lean tools such as 5S, Kanban, VSM etc.
- Solid understanding of Industry regulations as it pertains to medical devices
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