At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Position Brand Description:
Indy Device Manufacturing (IDM) is an external facing team responsible for the manufacturing of medical devices and the delivery of the custom assembly equipment utilized as part of the manufacturing process. Automation engineers oversee the technical aspects of developing, designing, constructing, and delivering automated device assembly lines for IDM globally to both Lilly sites and Contract Manufacturers in support of new product launches, capacity expansions, and line extensions. Automation engineers in IDM work closely with Original Equipment Manufacturers (OEM) to design and build custom medical device assembly machines. These engineers also develop and implement best practices for design and startup of device assembly lines and deploy systems to capture and utilize process data.
Key Objectives/ Deliverables:
Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitabilitySupport all aspects of tool and process validations including computer system validation. Includes creation, execution and coordination of validation activities in partnership with Contract Manufacturers.Manage the generation rationalization of user requirements for each projectDefine and mitigate technical and patient risks, including use of FMEAAssure each design includes maximum appropriate re-use of technology from prior projectsOversee OEM's design process, assuring questions are resolved and barriers to progress are removedConduct thorough design reviews to assure design meets requirements and local/corporate standardsCharacterize unit operations and set operating conditions as required by defining an Engineering Studies plan, developing rigorous studies and executing themAssure testing is appropriately developed and is in accordance with the risk level of the item being testedDocument research and investigations as technical reportsComplete engineering activities involved in the development of process/product improvements. This includes project planning activities, development of protocols, coordination of internal and external lab based testing, documentation of the data and completion of technical reports.Work with external companies and project teams to develop product and process improvements.Ensure that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.Coordinate/lead cross-functional/cross-site/cross-company engineering project teams as needed.Participate on Commercialization project teams for new devices with focus on manufacturing readiness. Lead cross-functional/cross-site/cross-company project teams as needed.Identify and implement process and product changes necessary to maintain, sustain and improve the manufacturing process.Support Technical Stewardship projects to improve device design.Minimum Requirements:
BS in an Engineering or Engineering related fieldMinimum 2 years engineering experience, preferably in ManufacturingAdditional Preferences:
Medical Devices experiences preferredExperience with DOE and statistical methods as applied to engineering studies and reportsExperience in large capital project delivery and management of sub-projects within a larger projectDemonstrated high degree of ownership / accountabilityExperience with engineering in a regulated pharmaceutical environment/cGMPs/Commissioning and QualificationExperience in programming control systems for high-speed assembly linesStrong communication, teamwork, and networking skillsExpertise in automation networks, vision systems for part inspection, debugging of assembly linesSolid technical writing skillsProven ability to organize and prioritize multiple tasksStrong attention to detailProven problem solving skillsAbility to work independently as well as in a team environmentOther Information: Ability to travel 25% on average with peak over 50% for a few months at a time
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