Medical Device Manufacturing Engineer: NPI & Lean

Siemens Healthineers AG; Rockford (IL); Híbrido; USD 110.000 - 152.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid time off

Parking or transit

Resumo da vaga

Siemens Healthineers in Rockford, IL is seeking a hands-on Manufacturing Engineer to optimize manufacturing processes and support new product introductions on-site with hybrid flexibility.

You will work with Production, Quality, Engineering, and Supply Chain to drive process improvements, ensure regulatory compliance, and train teams for successful manufacturing launches and ongoing operations.

Qualificações

• Bachelor's degree in Manufacturing or Industrial Engineering or related field.
• Minimum of 5 years of manufacturing engineering experience in a regulated environment (medical device preferred).
• Experience in process development, validation, optimization, and continuous improvement.
• ERP/MRP experience, preferably SAP.
• Lean, Six Sigma, and Operational Excellence knowledge.
• SPC, data analysis, and statistical methods experience.
• EHS programs, audits, and regulatory compliance exposure.
• Knowledge of FDA QSR and 21 CFR Part 820/11; MVPs, IQ/OQ/PQ basics.

Responsabilidades

• Develop manufacturing process flows, SOPs, MPIs, and support ECOs and BOMs.
• Lead sustaining engineering and continuous improvement initiatives to boost productivity and quality.
• Apply SPC and data analysis to maintain process capability and stability.
• Investigate issues, perform root cause analysis, and implement CAPAs.
• Support regulatory compliance and quality system activities and audits.
• Provide technical guidance and training to manufacturing personnel and cross-functional teams.
• Promote EHS and a safe, compliant work environment.

Conhecimentos

Process development

Process validation

Continuous improvement

SPC

Data analysis

Regulatory compliance

EHS programs

Problem solving

Cross functional

Formação

Bachelor's degree in Manufacturing Engineering, Industrial Engineering, or related engineering discipline

Ferramentas

SAP

MRP systems

MS Office

Descrição da vaga

Siemens Healthineers in Rockford, IL is seeking a hands-on Manufacturing Engineer to optimize manufacturing processes and support new product introductions on-site with hybrid flexibility.

You will work with Production, Quality, Engineering, and Supply Chain to drive process improvements, ensure regulatory compliance, and train teams for successful manufacturing launches and ongoing operations.