Industrial Engineer

Siemens Healthineers

11d•$110,220 - $151,558•Hybrid

About The Position

Siemens Healthineers is seeking a motivated, hands-on Manufacturing Engineer to collaborate with Production, Quality, Engineering, Supply Chain, and Operations. The role focuses on optimizing manufacturing processes, improving productivity, and supporting new product introductions in a regulated manufacturing environment. It is an on-site position with hybrid work flexibility; limited travel may be required for training and collaboration with other Siemens Healthineers locations. The engineer supports new product introduction and sustaining engineering, applies Lean and Six Sigma methods, uses statistical tools to monitor process capability, and investigates manufacturing and quality issues. The role also supports regulatory compliance, quality systems, employee training, and environmental, health, and safety initiatives.

Requirements

Bachelor's degree in Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
At least 5 years of manufacturing engineering experience in a regulated manufacturing environment; medical device industry experience is preferred.
Experience in manufacturing process development, process validation, manufacturing optimization, and continuous improvement.
Experience with Enterprise Resource Planning (ERP) or Material Requirements Planning (MRP) systems; SAP is preferred.
Working knowledge of Lean Manufacturing, Six Sigma, and Operational Excellence principles.
Experience applying SPC, statistical sampling methodologies, and data analysis techniques to manufacturing processes.
Experience supporting 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.
Knowledge of process validation methodologies and documentation, including Master Validation Plans (MVPs), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Experience with BOMs, ECOs, Device History Records (DHRs), process flow diagrams, specifications, and related engineering documentation.
Strong analytical, troubleshooting, and problem-solving skills, including the ability to make data-driven decisions.
Proficiency with Microsoft Office applications and commonly used engineering software tools.
Excellent written and verbal communication skills and ability to collaborate across functions and organizational levels.

Nice To Haves

Lean Six Sigma Green Belt or Black Belt certification.
Medical device industry experience.
Experience with SAP.

Responsibilities

Support New Product Introduction (NPI), including developing manufacturing process flows, Standard Operating Procedures (SOPs), and Manufacturing Process Instructions (MPIs), and supporting ERP activities such as Engineering Change Orders (ECOs) and Bills of Material (BOMs), manufacturing readiness, process transfers, and production launches.
Lead sustaining engineering and continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies to improve efficiency, product quality, and operational performance.
Use statistical methods, Statistical Process Control (SPC), process monitoring, and data analysis to maintain process capability, stability, and repeatability.
Investigate manufacturing and quality issues, conduct root cause analyses, and implement Corrective and Preventive Actions (CAPAs).
Support quality-system and regulatory-compliance activities, including audits, inspections, process validations, and related technical documentation.
Provide technical guidance, troubleshooting support, and training to manufacturing personnel and cross-functional teams.
Support Environmental, Health, and Safety (EHS) initiatives, programs, and regulatory requirements to promote a safe and compliant workplace.