Manufacturing Engineer II - Medical Devices NPI & Lean

MGC Diagnostics; Saint Paul (MN); Vor Ort; USD 77.000 - 98.000; Vollzeit

Zusammenfassung

MGC Diagnostics in Saint Paul, MN is seeking a Manufacturing Engineer II to advance development, improve reliability, and drive production readiness of medical diagnostic instruments. You will collaborate across Engineering, Manufacturing, Quality, Supply Chain, and suppliers to resolve complex sensor, electronics, and test system challenges.

The role emphasizes lean and Six Sigma methods, process validation, and documentation in ISO 13485 environments, plus ongoing improvements to cost,

Qualifikationen

• Bachelor’s degree in engineering or related technical discipline, or equivalent experience.
• Minimum of 3 years in engineering; advanced degree may reduce experience
• Experience in a regulated industry; medical device experience preferred.
• Experience troubleshooting sensors, analog and digital circuits, PCB assemblies, instrumentation, electronics manufacturing, or production test.
• Strong English communication skills; able to manage multiple tasks.

Aufgaben

• Transition products from design to production with manufacturing processes and work instructions.
• Plan pre-release and pilot builds to evaluate manufacturability and production readiness.
• Develop and improve production fixtures, tooling, and test methods.
• Support supplier selection and first article inspection; collaborate with suppliers to improve quality and capacity.
• Resolve production issues; apply Lean, Six Sigma, DMAIC, DOE to reduce waste and improve quality.
• Troubleshoot assemblies, sensors, production equipment, and test systems.
• Ensure compliance with ISO 13485 and regulatory requirements; maintain process validation activities.

Kenntnisse

English communication

Multi-tasking

Analytical thinking

Root cause analysis

Ausbildung

Bachelor’s degree in engineering or related field

Advanced degree preferred

Tools

SolidWorks

3D CAD tools

Jobbeschreibung

MGC Diagnostics in Saint Paul, MN is seeking a Manufacturing Engineer II to advance development, improve reliability, and drive production readiness of medical diagnostic instruments. You will collaborate across Engineering, Manufacturing, Quality, Supply Chain, and suppliers to resolve complex sensor, electronics, and test system challenges.

The role emphasizes lean and Six Sigma methods, process validation, and documentation in ISO 13485 environments, plus ongoing improvements to cost,