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External Manufacturing Operations Engineer
External Manufacturing Operations EngineerSiemens Healthineers • Newark, DE, United States
External Manufacturing Operations Engineer

External Manufacturing Operations Engineer

Siemens Healthineers • Newark, DE, United States
2 days ago
Job type
  • Full-time
Job description

External Manufacturing Operations Engineer

Join Siemens Healthineers as an External Manufacturing Operations Engineer.

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.

Responsibilities :

  • 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.

Requirements :

  • Bachelors degree in Chemistry, Biochemistry, Engineering, Medical Technology, Biology, or a related discipline, with 58 years of relevant industry experience or an advanced degree (M.S. or Ph.D.) in a related field with 13 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.
  • What We Offer :

    Competitive salary range : $128,100 - $192,200 per year. Benefits include 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, and 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.

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