NPI Manufacturing Engineering Manager @ Work as a team of 6 mechanical, system level, manufacturing engineers whom oversee the design and development of the next generation medical-robot assembly processes. Our team owns the complete design and implementation of new assembly process from Alpha life-cycle through hand-off to sustaining. The team drives process capability studies to ensure processes
NPI Manufacturing Engineering Manager @ Work as a team of 6 mechanical, system level, manufacturing engineers whom oversee the design and development of the next generation medical-robot assembly processes. Our team owns the complete design and implementation of new assembly process from Alpha life-cycle through hand-off to sustaining. The team drives process capability studies to ensure processes are repeatable, reliable, and meet final manufacturing review requirements prior to the lines transfer.
• Develop, validate and release assembly processes for complex medical devices both internally as well as for C.M. location.
• Design, qualify, and implement electro-mechanical fixtures/tooling/aides.
• Drive root cause investigations of line defects and implement systemic corrections.
• Develop and implement process improvements to reduce waste, eliminate variation, reduce defects, and improve yield.
• Develop and release PFMEA documentation and complete trace-closure activities for high patient risk processes.
• Vertically integrate/in-source large robotic structure which resulting in significant cost savings. From October 2012 to Present (3 years 3 months) Manufacturing Engineering Manager @ Lead Systems Manufacturing Engineering team of 4 in charge of line support, continuous improvement projects, reliability improvements, cost reduction efforts, process improvements, and fixtures (design, implementation and maintenance).
• CAPA team member: Contributed to defect resolution at a CAPA level within the organization. Owned and contributed to CAPA projects.
• IQC VR reduction: Reduced fallout of incoming parts by 70% through Cpk summary of IQC data vs line performance.
• Moderate cost savings implemented through outsourcing and material changes. From August 2010 to October 2012 (2 years 3 months) Senior Manufacturing Engineer/Technical Lead @ Leadership responsibilities included assisting in goal development, aligning team objectives cross-functionally, and tracking teams performance. Individual responsibilities were centered on line support, field complaint improvements, cost reduction activities, and process improvements.
• Conducted DOE to analyze increasing complaint rate of the cannula mount assembly. Implemented corrected design and supported production cut-in and field activities as Manufacturing Engineer.
• Designed and Implemented cost reduction projects (material changes and part count reduction) resulting in moderate annual cost savings.
• Point contact for CM facility that produced large robotic structure. Implemented and lead quality review initiative that drove visibility and ownership of defect trends. From November 2009 to August 2010 (10 months) Manufacturing Engineer @ • Designed and conducted DOE to develop root cause of brake shaft migration. Engaged and lead cross-functional team to resolve low occurrence/high severity failure mode. Implemented systemic fix and lead field rework initiative.
• Designed and implemented redesign of PSC steering linkage pin. Design change addressed rising field complaints stemming from manufacturing process tolerance stack. Design eliminated failure mode and provided field with a simple replacement process.
• Developed requirements, supported development, and drove implementation of system level test fixture at CM. Fixture allowed us to push defect detection upstream and eliminate DOA of large robotic structure at our facility upon arrival. From August 2008 to November 2009 (1 year 4 months) Manufacturing Engineer / Production Supervisor @ • Supported NPI team on Validation and Verification of releases, new production line establishment on launch of next generation product (IS3000) and subassembly cut in.
• Systems manufacturing support for DHR system migration from ISMES to SAP.
• Designed and released multiple production fixtures including automated PSM insertion axis friction tester, link 1 and 2 brake pin press handle. From May 2005 to August 2008 (3 years 4 months) Manufacturing Engineer @ From May 2003 to April 2005 (2 years) Mechanical Design contractor @ From January 2002 to May 2003 (1 year 5 months) Intern @ From 2000 to 2000 (less than a year)
BS, Mechanical Engineer @ San Jose State University Craig Shawver is skilled in: Design for Manufacturing, Manufacturing Engineering, Manufacturing, Product Development, Medical Devices, Design of Experiments, ISO 13485, Design Control, Robotics, Mechanical Engineering, Lean Manufacturing, FMEA, Quality System, R&D, Machining
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