Manufacturing Engineer

Responsibilities

• Design, develop, and optimize manufacturing processes to improve yield, quality, and throughput
• Troubleshoot production issues in real time and implement sustainable solutions
• Lead or support continuous improvement initiatives using Lean, DOE, and data analysis
• Reduce scrap and improve efficiency through process, tooling, and equipment improvements
• Partner cross-functionally with Production, Quality, and Engineering teams
• Support validations, FMEAs, CAPA activities, and process documentation

Requirements

• Mandatory: Manufacturing engineering experience (3-5 years)
• Mandatory: Experience in a regulated environment (medical device, pharma, or similar)
• Mandatory: Hands-on troubleshooting and process improvement experience
• Mandatory: Familiarity with Lean / continuous improvement methodologies

Nice-to-Have Qualifications

• Clean-room manufacturing experience
• DOE, FMEA, CAPA experience
• Knowledge of FDA/ISO regulations (21 CFR Part 820)

About the Role

We’re hiring a Manufacturing Engineer to support and improve clean-room manufacturing processes for medical device products. This is a highly hands-on role where you’ll work directly on the production floor to solve problems, optimize processes, and drive measurable improvements in performance and quality.