IDM TS/MS Product Steward (R2-R3)

Eli Lilly and Company seeks an IDM TS/MS Product Steward (R2-R3) to develop potential product and process improvements. Responsible for design control, validation and verification activities, and manufacturing control strategy. Develop specifications, protocols, sampling plans, engineering studies, and technical reports. Provide support to product lifecycle management and monitoring processes. Organize and facilitate Failure Modes, and Effects Analysis (FMEA) meetings and lead on multi-functional project teams. Lead root cause investigation team to develop and implement corrective and preventative actions. Participate in and support CMO Joint Process Teams to meet manufacturing objectives. Participate in Design and Manufacturability reviews. #LI-DNI Position requires a Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering field and 3 years of experience working in technical services/manufacturing sciences, engineering, quality, development, or manufacturing/packaging in a regulated manufacturing operations environment. Experience must include a minimum of: 3 years of experience working with CAD software packages (Solidworks, ProE, Inventor) and GD&T drawing practices; 3 years of experience driving continuous improvement of test systems and validation processes; 3 years of experience leading analytical evaluations of events and deviations associated with products, test systems, and analytical methods; 3 years of experience working with device platforms, including design, materials of constructions, manufacturing process, and quality systems; 3 years of experience working with Primary Loop, Operational Excellence, and Root Cause Analysis; and 3 years of experience working with drug product and medical device regulatory requirements, including cGMP, 21 CFR 820,ISO 13485, and ISO11608. Up to 10% domestic and international travel required. #LI-DNI Job location: Indianapolis, IN. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-103503 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285.