We are seeking an engineer to plan, execute, and implement the supply chain for ultrasound products. The engineer will be responsible for the product quality process efficiency in manufacturing, and product/process change control. In the organization, the engineer will work with multiple different internal functions including NPI, R&D, and operation groups, as well as external suppliers.
Coordinate activities to assure supply chain material readiness and quality for any design change or process change
Release and implement engineering change orders (ECOs) related to design transfer to manufacturing
Engage with operations, vendors and contract manufacturers to ensure timely production of material and service
Develop and optimize manufacturing processes for new and existing that reduces costs, labor, product variability and improves lead time and yield
Provide timely resolution of product, process and equipment problems in the form of short and long term solutions, and understand root cause to implement CAPA and avoid recurrence
Identify efficiency gains and process improvements in manufacturing
Participate in cross functional teams with focus on manufacturing efficiency and standardization (specifically validation, labeling, assembly, testing, packaging, and engineering change orders)
Lead cross-functional team for production projects and communicate project expectations effectively to team members (both internal and external) and stakeholders
Conduct product supply chain evaluation, verification, and validation
Drive root cause analysis and corrective actions with teams for customer complaints in the field or process failures in the factory
Drive continuous quality improvement initiatives resulting from internal and external audits
Provide knowledge-based technical support on both product and process
Required Knowledge/Skills, Education, and Experience
- BS in BME/BioE, EE, IE, ME, or related discipline or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
5+ years relevant working experience or equivalent education.
Familiar with Microsoft Windows Office tools (Excel, Word, Visio, and Powerpoint)
Project management or engineering experience in manufacturing
Sense of urgency, ownership, and accountability with strong organizational skills
Effective communicator internally and externally
Experience in process development for both business and manufacturing.
Experience with manufacturing process/equipment validation
Strong knowledge and experience with root cause analysis and corrective action
Strong knowledge and experience with production floor layout for optimal work process and material flow.
Ability to travel 10% to 15%
Preferred Knowledge/Skills, Education, and Experience
- Work experience with SAP is highly desired
- Work experience with Microsoft Team Foundation Server
- Work experience with medical device manufacturing
- Knowledge in medical device regulations including ISO 13485 and CFR 820
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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