Siemens Healthineers-posted 3 months ago
$128,100 - $192,200/Yr
Full-time • Mid Level
5,001-10,000 employees

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.

  • 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.
  • Review and approve verification, qualification, and validation protocols and results conducted at OEM sites.
  • Lead or coordinate in-house testing when necessary.
  • Provide technical assessments for Supplier Change Notices.
  • Lead and coordinate escalations of OEM-initiated change notices to the Change Review Board (CRB).
  • 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.
  • Bachelor’s degree in Chemistry, Biochemistry, Engineering, Medical Technology, Biology, or a related discipline.
  • 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.
  • Excellent interpersonal and communication skills.
  • Strong track record of delivering results by balancing technical solutions with business objectives.
  • Skilled in interpreting complex data sets and troubleshooting technical issues.
  • Proficient in Microsoft Office applications and statistical analysis tools.
  • Demonstrated high-level critical thinking and problem-solving capabilities.
  • Self-motivated and capable of working independently while managing complex and ambiguous tasks.
  • Flexible and willing to travel, including availability for short-notice domestic and international assignments.
  • 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
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