Lead interfaces with internal customers and external suppliers to rapidly develop appropriate measurement methods, specify metrology equipment, define robust staging fixtures and program metrology instruments in support of medical product programs. Candidate will work with US sites and contract manufactures across our Pharma, Solutions, Surgical and other businesses. Supporting engineering activity for development, capacity expansion, continuity of supply and maintenance of business type projects.
Applied Metrology Engineering project leadership:
• Develop mechanical measurement systems and fixtures for closure systems, ophthalmic medical devices, molds, mold inserts, gages, and plastic and metal parts and components.
• Drive the qualification of new measurement methods and testing equipment.
• Develop and implement test procedures, SOP’s and protocols.
• Lead investigations and root cause analysis in support of manufacturing sites and outside component suppliers.
• Ability to write analytical reports and provide sound rationale for investigations.
• Perform mechanical testing, analyze data and prepare reports.
• Measure mechanical features using coordinate measuring machines (CMM), video-based inspection and measurement equipment (e.g. SmartScope), and gauges.
• Programming leadership on SmartScope and CMM.
• Consult and guide site/supplier end users on training and maintenance of new fixtures and equipment.
• Effectively interface with various internal and external groups during the development cycle supporting part design, guide appropriate dimensioning and select critical to function elements of design to drive robust Design for Manufacturability.
• Project leadership and supplier management of US Engineering site driven activities.
• Ability to drive projects remotely and travel to sites and suppliers (domestic travel ~1 week ever 6-8weeks; project driven)
Education: BS in Mechanical Engineering or Scientific/Engineering discipline with relevant technical experience.
Experience: • 7-12 years in a research or industrial setting with good verbal and written communication. Practiced in technical documentation skills in a regulated environment. Ability to work well on a multi-disciplinary team in a fast-paced, multitasking environment. Advanced troubleshooting skills a must. Proficient with Microsoft Office and Excel. Statistical analysis experience required (ANOVA, capability and correlation analysis)
Special Skills: External technology/metrology partners (i.e. OGP, QVI, Brown & Sharpe, Heidenhain, Optikos, Rehder, Mitutoyo, Keyence, Mark10, etc). Familiarity with metrology instruments and associated use/programming.
Specialized Training: CMM programming leadership, Practical experience in conducting Gage R&R and Correlation studies, working knowledge of CAD software (e.g. SolidWorks™), Practical knowledge of GD&T. Practical experience with injection plastic molding, practical machine shop experience, and familiarity with a regulated environment under change control discipline (e.g. FDA and ISO). ISO-9000 and GMP experience desired.
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