Manufacturing Engineer II — Medical Diagnostics Process

MGC Diagnostics; Northern (KY); Hybrid; USD 85,000 - 100,000; Full time

Job summary

MGC Diagnostics is seeking a Manufacturing Engineer II to support development, improvement, and production readiness of medical diagnostic instruments. You will work with Engineering, Manufacturing, Quality, Supply Chain, and suppliers to resolve issues, improve processes, and ensure production readiness.

The role emphasizes lean and Six Sigma methods, process validation, and compliance with ISO 13485 in a fast-paced manufacturing setting.

Qualifications

• Bachelor’s degree in engineering or related technical discipline required.
• Minimum of 3 years experience in engineering; advanced degree may substitute experience.
• Experience in a regulated industry; medical device experience preferred.
• Experience troubleshooting products and manufacturing systems involving sensors, electronics, or test systems.
• Strong written and verbal English communication; ability to manage multiple tasks.

Responsibilities

• Transition products from design to production by developing manufacturing processes and work instructions.
• Plan and execute pre-release and pilot builds to evaluate manufacturability and production readiness.
• Develop and improve fixtures, tooling, equipment, and test methods.
• Collaborate with engineering, quality, manufacturing, and suppliers to resolve issues and ensure component availability.
• Apply Lean, Six Sigma, DMAIC, DOE, and statistical methods to reduce waste and improve quality and cost.
• Troubleshoot assemblies and production equipment; analyze data to identify root causes and implement corrective actions.
• Maintain compliance with ISO 13485 and regulatory requirements; support validation activities.

Skills

English communication

Multi-tasking

Analytical thinking

Education

Bachelor’s degree in engineering

Advanced degree welcomed

Tools

SolidWorks

Statistical methods

Job description

MGC Diagnostics is seeking a Manufacturing Engineer II to support development, improvement, and production readiness of medical diagnostic instruments. You will work with Engineering, Manufacturing, Quality, Supply Chain, and suppliers to resolve issues, improve processes, and ensure production readiness.

The role emphasizes lean and Six Sigma methods, process validation, and compliance with ISO 13485 in a fast-paced manufacturing setting.