Industrial Engineer

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

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:

We are a team of more than 72000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision‑making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

The base pay range for this position is: $110,220 - $151,558. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company’s plan. Commissions are based on individual performance and/or company performance.

Benefits:

• medical insurance, dental insurance, vision insurance, 401(k) retirement plan.
• life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement:

Siemens Healthineers is an Equal Opportunity and affirmative action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Reasonable Accommodations:

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

California Privacy Notice:

California residents have the right to receive additional notices about their personal information.

Export Control:

“A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

Data Privacy:

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.

We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in‑vitro and in‑vivo diagnostics to image‑guided therapy and innovative cancer care, is crucial for clinical decision‑making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.