Manufacturing Engineer - NPI & Lean Six Sigma (Medical)

563d Siemens Medical Solutions USA, Inc.; United States; Hybrid; USD 110,000 - 152,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Job summary

Siemens Healthineers is seeking a hands-on Manufacturing Engineer to optimize processes, support NPI, and drive continuous improvement across production, quality, and supply chain. The role involves leading CAPA investigations, developing SOPs, and liaising with ERP systems such as SAP.

The ideal candidate has 5+ years in regulated manufacturing, strong analytical skills, and experience with FDA QSR and 21 CFR Part 820. On-site with hybrid flexibility, limited travel may be required.

Qualifications

• Bachelor's degree in Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
• Minimum of 5 years of manufacturing engineering experience in a regulated manufacturing environment, preferably within the medical device industry.
• Experience with ERP/MRP systems, preferably SAP.
• Lean Manufacturing, Six Sigma, and Operational Excellence principles.
• Experience applying SPC, statistical sampling methodologies, and data analysis techniques to manufacturing processes.
• Experience supporting Environmental, Health, and Safety (EHS) programs, quality management systems, audits, inspections, and regulatory compliance activities.
• Knowledge of FDA Quality System Regulations, including 21 CFR Part 820 and 21 CFR Part 11.
• Experience with BOMs, ECOs, DHRs, process flow diagrams, specifications, and related engineering documentation.
• Strong analytical, troubleshooting, and problem-solving skills, with the ability to make data-driven decisions.

Responsibilities

• Supporting New Product Introduction (NPI) activities, including developing manufacturing process flows, SOPs, MPIs, and supporting ERP activities such as ECOs and BOMs.
• Manufacturing process development, process validation, manufacturing optimization, and continuous improvement initiatives.
• Applying Lean Manufacturing and Six Sigma to enhance efficiency, product quality, and operational performance.
• Using SPC, process monitoring techniques, and data analysis to maintain process capability and stability.
• Investigating manufacturing and quality issues, conducting root cause analyses, and implementing CAPAs.
• Supporting regulatory compliance and quality system activities, including audits and process validations.
• Providing technical guidance and training to manufacturing personnel and cross-functional teams.

Skills

Lean Manufacturing

Six Sigma

Operational Excellence

SPC

Data analysis

Root cause analysis

Cross-functional collaboration

Problem-solving

Education

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

Tools

SAP

Job description

Siemens Healthineers is seeking a hands-on Manufacturing Engineer to optimize processes, support NPI, and drive continuous improvement across production, quality, and supply chain. The role involves leading CAPA investigations, developing SOPs, and liaising with ERP systems such as SAP.

The ideal candidate has 5+ years in regulated manufacturing, strong analytical skills, and experience with FDA QSR and 21 CFR Part 820. On-site with hybrid flexibility, limited travel may be required.