Manufacturing Engineer II, Medical Devices

Caire-Inc-4; Saint Paul (MN); Presencial; USD 85.000 - 100.000; Tempo integral

Resumo da vaga

MGC Diagnostics is seeking a Manufacturing Engineer II MGC in Saint Paul, MN to support development, production readiness, and process improvements for medical diagnostic instruments. You will work with Engineering, Quality, Manufacturing, Supply Chain and suppliers to optimize sensors, electronics, fixtures and test systems, applying Lean, Six Sigma, and DMAIC methods.

Qualifications include a Bachelor's in engineering and at least 3 years in a regulated environment; strong English

Qualificações

• Bachelor’s degree in engineering or a related technical discipline.
• Minimum of 3 years’ experience in Engineering; regulated industry experience preferred.
• Experience troubleshooting products and manufacturing systems involving sensors, electronics, PCB assemblies or test systems.
• Ability to analyze requirements, evaluate technology and develop innovative solutions.
• Excellent written and verbal communication in English.
• Ability to manage multiple tasks with flexible priorities.
• Strong written and verbal communication and collaboration skills.

Responsabilidades

• 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 and maintain component availability.
• Apply Lean, Six Sigma, DMAIC, DOE, and statistical methods to reduce waste and variation, improve flow and throughput, and optimize quality and 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 and implement corrective actions.
• Develop and execute risk-based process validation activities and maintain QA/QMS documentation.

Conhecimentos

Analytical thinking

Problem solving

Project management

Communication skills

English proficiency

Multi-tasking

Formação

Bachelor’s degree in engineering or related field

Ferramentas

SolidWorks

Descrição da vaga

MGC Diagnostics is seeking a Manufacturing Engineer II MGC in Saint Paul, MN to support development, production readiness, and process improvements for medical diagnostic instruments. You will work with Engineering, Quality, Manufacturing, Supply Chain and suppliers to optimize sensors, electronics, fixtures and test systems, applying Lean, Six Sigma, and DMAIC methods.

Qualifications include a Bachelor's in engineering and at least 3 years in a regulated environment; strong English