Industrial Engineer

Siemens Healthcare; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Siemens Healthineers in the United States is seeking a Manufacturing Engineer to optimize manufacturing processes, support new product introductions, and collaborate with cross-functional teams to improve quality and efficiency.

This on-site role offers hybrid flexibility and may require limited travel for training and collaboration across Siemens Healthineers locations. You will lead process improvements, perform data analysis, and ensure regulatory compliance.

Qualifications

• Bachelor's degree in Manufacturing or Industrial Engineering.
• Minimum 5 years in manufacturing engineering within a regulated environment.
• Experience with ERP/MRP systems, preferably SAP; Lean/Six Sigma and data-driven problem solving.
• Experience with SPC, CAPA, and quality systems in manufacturing.

Responsibilities

• Develop manufacturing process flows, SOPs, MPIs, and support ECOs and BOMs.
• Lead sustaining engineering and continuous improvement using Lean and Six Sigma.
• Apply SPC and data analysis to ensure process capability and stability.
• Investigate issues, perform root cause analyses, and implement CAPAs.
• Support regulatory audits, quality systems, and technical documentation.
• Provide guidance and training to manufacturing teams for consistent processes.
• Support EHS initiatives and maintain a safe manufacturing environment.

Skills

ERP systems SAP

Lean Manufacturing

Six Sigma

Statistical methods

Data analysis

SPC

Root cause analysis

CAPA processes

Microsoft Office

Education

Bachelor's degree in Manufacturing Engineering

Tools

SAP ERP

MS Office

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

At Siemens Healthineers, we are seeking a motivated and hands-on Manufacturing Engineer to join our team. In this role, you will collaborate with Production, Quality, Engineering, Supply Chain, and Operations to optimize manufacturing processes, improve productivity, and support new product introductions.

The ideal candidate is a proactive problem-solver who thrives in a collaborative manufacturing environment and enjoys developing practical solutions that improve product quality, process reliability, and operational performance.

Work Arrangement: This is an on-site position with hybrid work flexibility. Limited travel may be required for training and collaboration with other Siemens Healthineers locations.

You are responsible for:

• Supporting New Product Introduction (NPI) activities, including developing manufacturing process flows, Standard Operating Procedures (SOPs), 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.
• Leading sustaining engineering and continuous improvement initiatives by applying Lean Manufacturing and Six Sigma methodologies to enhance manufacturing efficiency, product quality, and operational performance.
• Utilizing statistical methods, Statistical Process Control (SPC), process monitoring techniques, and data analysis to maintain manufacturing process capability, stability, and repeatability.
• Investigating manufacturing and quality issues, conducting root cause analyses, and implementing effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.
• Supporting regulatory compliance and quality system activities, including internal and external audits, inspections, process validations, and associated technical documentation.
• Providing technical guidance, troubleshooting support, and training to manufacturing personnel and cross-functional teams to ensure consistent execution of manufacturing processes.
• Promoting a safe and compliant working environment by supporting Environmental, Health, and Safety (EHS) initiatives, programs, and regulatory requirements.

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.
• Demonstrated experience in manufacturing process development, process validation, manufacturing optimization, and continuous improvement.
• Experience working with Enterprise Resource Planning (ERP) or Material Requirements Planning (MRP) systems, preferably SAP.
• Working knowledge of Lean Manufacturing, Six Sigma, and Operational Excellence principles.
• Experience applying Statistical Process Control (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.
• Knowledge of process validation methodologies and documentation, including Master Validation Plans (MVPs), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience working with Bills of Material (BOMs), Engineering Change Orders (ECOs), Device History Records (DHRs), process flow diagrams, specifications, and related engineering documentation.
• Strong analytical, troubleshooting, and problem-solving skills, with the ability to make data-driven decisions.
• Proficiency with Microsoft Office applications and commonly used engineering software tools.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across multiple functions and organizational levels.

Preferred Qualifications:

• Lean Six Sigma Green Belt or Black Belt certification.

Desired Attributes:

• Self-motivated professional with a strong sense of ownership, accountability, and urgency in achieving objectives.
• Strong organizational, planning, analytical, and problem-solving capabilities.
• Ability to work independently while collaborating effectively with multidisciplinary teams.
• Comfortable managing multiple priorities and adapting to changing demands in a fast-paced manufacturing environment.
• Hands-on approach to identifying challenges, implementing improvements, and driving sustainable manufacturing solutions.

Who we are : W