Manufacturing Engineer II – Medical Diagnostics

MGC Diagnostics; Fort Snelling Unorganized Territory (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

MGC Diagnostics in Minnesota seeks a Manufacturing Engineer II to support the development, improvement, and production readiness of medical diagnostic instruments. You will enhance product reliability and manufacturability while collaborating with Engineering, Quality, and Supply Chain.

The role requires a Bachelor’s in engineering and 3+ years in a regulated environment, with experience in sensors, electronics, PCB assemblies, and production testing.

Qualifications

• Bachelor’s degree in engineering or related technical discipline, or equivalent relevant experience.
• Minimum of 3 years’ experience in engineering, preferably in regulated/medical device.
• Experience troubleshooting products and manufacturing systems involving sensors, analog/digital circuits, PCB assemblies, or production test.
• Ability to communicate effectively in English, both written and verbal.
• Ability to manage multiple tasks with flexible priorities.

Responsibilities

• New Product Introduction and transition medical diagnostic products from design to production by developing manufacturing processes, risk-based controls, and production work instructions.
• Plan and execute pre-release and pilot builds to evaluate manufacturability, test performance, process capability, and production readiness.
• Develop, qualify, and improve production fixtures, tooling, equipment, and test methods.
• Support supplier selection, ramp-up, and first article inspection, and partner with suppliers to improve quality, capacity, process capability, and manufacturing readiness.
• Collaborate with Engineering, Quality, Manufacturing, Supply Chain, and suppliers to resolve production issues, maintain component availability, and sustain product and process performance.
• Apply Lean, Six Sigma, DMAIC, DOE, and statistical methods to reduce waste and variation, improve flow and throughput, and optimize quality and manufacturing cost.
• Troubleshoot electronic assemblies, sensors, instrumentation, production equipment, fixtures, and automated or software-assisted test systems.
• Analyze production and test data to identify root causes of failures, yield loss, process drift, and test variation, and implement effective corrective and preventive actions.
• Quality Assurance: Develop and execute risk-based process validation activities, including protocols, statistical analyses, acceptance criteria, reports, and ongoing process-capability monitoring.
• Maintain manufacturing processes and documentation in compliance with the company quality management system, ISO 13485, and applicable regulatory requirements.

Skills

Troubleshooting

English communication

Lean Six Sigma

Process improvement

Education

Bachelor’s degree in engineering

Tools

SolidWorks

Job description

MGC Diagnostics in Minnesota seeks a Manufacturing Engineer II to support the development, improvement, and production readiness of medical diagnostic instruments. You will enhance product reliability and manufacturability while collaborating with Engineering, Quality, and Supply Chain.

The role requires a Bachelor’s in engineering and 3+ years in a regulated environment, with experience in sensors, electronics, PCB assemblies, and production testing.