External Manufacturing Operations Engineer

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.

This is a role well suited to an ambitious professional, looking for the next step in their career.

As a External Manufacturing Operations Engineer, you will be responsible for:

• Serve as the primary liaison with OEM partners for all manufacturing-related activities involving finished products within the Laboratory Systems Business Unit.
• Ensure adherence to Siemens Healthineers’ Quality Management System. Familiarity with Supplier Corrective Action Reports (SCAR) and Corrective and Preventative Actions (CAPA) is highly desirable.
• Review and approve verification, qualification, and validation protocols and results conducted at OEM sites, particularly during the commissioning of key equipment and components for Siemens-owned, supplier-operated assets. Lead or coordinate in-house testing when necessary.
• Provide technical assessments for Supplier Change Notices, including changes to manufacturing processes, raw materials, in-process testing, equipment, and manufacturing locations, in collaboration with Technical Operations.
• Lead and coordinate escalations of OEM-initiated change notices to the Change Review Board (CRB), including associated documentation and testing. Manage the implementation of Siemens Healthineers-initiated changes at OEM sites.
• Manage capital and expense budgets for Siemens-owned, supplier-operated equipment. Collaborate with suppliers and Siemens finance teams to ensure assets are properly funded, maintained, and have sufficient capacity. Prepare and submit Applications for Investment (AFIs) as needed.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers:

• Excellent interpersonal and communication skills, with a proven ability to collaborate across organizational boundaries, build effective networks, and thrive in a team-oriented environment.
• Strong track record of delivering results by balancing technical solutions with business objectives, consistently meeting deadlines and project milestones.
• Skilled in interpreting complex data sets and troubleshooting technical issues to drive effective resolution.
• Proficient in Microsoft Office applications and statistical analysis tools.
• Demonstrated high-level critical thinking and problem-solving capabilities, including experience in problem containment, root cause analysis, documentation, and implementation of corrective actions.
• Self-motivated and capable of working independently while managing complex and ambiguous tasks with minimal supervision.
• Flexible and willing to travel, including availability for short-notice domestic and international assignments.

Required skills to have for the success of this role

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, Medical Technology, Biology, or a related discipline, with 5–8 years of relevant industry experience or an advanced degree (M.S. or Ph.D.) in a related field with 1–3 years of applicable experience.
• Proven experience working in regulated environments, such as those governed by FDA, ISO, or other quality and compliance standards.
• Background in manufacturing or engineering support for products used in the diagnostics, medical device, or pharmaceutical industries.

Who we are: We are a team of more than 73,000 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.

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