Lead Manufacturing Engineer

该职位是史赛克（Stryker）苏州工厂的资深制造工程师，负责领导工艺开发与改进、过程验证、以及跨部门协作

Provide advanced technical and engineering support to a project or function. 2. Ensure quality of process and product as defined in appropriate OS and Material specifications. 3. Ensure GMPs and system safety. 4. Lead PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and scale ups. 5. Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. 6. Provide training for manufacturing team members. 7. Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner. 8. Communicate and participate in system and process troubleshooting with support team members and with external agents. 9. Lead and participate cross functional and cross divisional process improvement initiatives. 10. Identify, quantify, and implement opportunities to reduce cost of goods. 11. Provide engineering support to the Advanced Operations (AO) team for new Product and new process introduction. 12. Conduct Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation. 13. Conduct Gauge R&R studies for products and new processes. 14. Application and development of statistical tools for use in driving continuous improvement projects. 15. Manage non-conformities (NC) and Corrective/Preventive Actions (CAPA) with the QA departments. 16. Responsible for assisting in the development of a global team that is proficient in process improvement and problem solving manufacturing issues using Six-Sigma tools. 17. Providing technical leadership on all product and process issues. 18. Leading technical improvements under the business’s Continuous Improvement Program (CIP). 19. Provision of technical leadership/guidance for the Process / maintenance Technicians and other Manufacturing / Equipment Engineers on the team. 20. Responsibility for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate. 21. Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets. 22. Fostering a work environment of continuous improvement that supports SYK’s Quality Policy, Quality System, and the appropriate regulations for the area they support, in particular ensuring that employees are trained to do their work and their training is documented. 23. Project management, resource prioritization, demonstrated experience in the development and execution of project plans (including time, budget and quality metrics) will be appreciated. 24. Demonstrate proficiency in quality & regulatory compliance. 25. Undertaking, where appropriate, a Subject Matter Expert’s role. 26. Coach Associate Engineer & Engineer in their development. 27. All other duties as assigned.

经验要求：Experience in CNC or other manufacturing processes; Experience in developing and working with small group problem solving teams; Experience on process development; Experience medical device industry is preferred; Experience on process quality. 教育背景：ISO 13485/Quality Systems Expertise and Application; GMP/Medical Device Industry Expertise is preferred; Lean/SPC is preferred.