Assoc Sr Consultant Engineer-IDM
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.
This position will provide technical leadership within the IDM Engineering team to lead aspects of scope development, design, delivery, and optimization of manual and automated device assembly processes and related equipment in support of IDM and Device network objectives for product commercialization, capacity expansion, and ongoing operations. The role is responsible for identifying and ensuring requirements for new products and processes are established with a focus on automated process assembly. This role also provides leadership for manufacturing platform consistency and continuous improvement and serves as the responsible engineer defined in local quality practices.
Key Objectives/ Deliverables:
This role is positioned as a senior technical resource supporting commercialization and manufacturing. The following list represents areas of responsibility across the product lifecycle:
Commercialization
- Perform Design for Manufacturability reviews; consult with and influence the Device R&D team to develop component designs that are compatible with the requirements of automated assembly and the scale of required production.
- Assure that tolerances, orientation features, materials, part interaction, ability to feed are appropriate for application.
- Lead and facilitate requirements, pFMEA, and control strategy generation; identify and mitigate patient risk that may arise from equipment design.
- Generate and/or interpret the Assembly Process Specification in the context of a project to design automated assembly equipment.
- Work with project teams to select equipment OEMs.
- Represent the engineering function in Due Diligence activities for business development.
- Identify and introduce new device assembly process technology strategies to optimize capital utilization and minimize time-to-volume.
- Support and influence assembly technology development initiatives.
- Assist or lead derisking/proof-of-concept work for new processes or technologies.
- Develop business case for application of technology.
Project/Asset Delivery
- Mentor technical team members with focus on recent campus grads and project technical leads.
- Consult with project teams on technical strategies, technical risks, and risk mitigation.
- Initiate and/or support proof-of-principle applications with OEM’s and the CTC.
- Serve as SME in technical studies as required to support project delivery.
- Troubleshoot major issues arising during debug or qualification of assets.
- Participate in design reviews of higher risk systems and/or those requested from the project team.
- Review and approve the technical study strategy and consult on interpretation of results.
Platform Support
- Provide troubleshooting support to operating assembly lines globally when problems are escalated beyond the local process team.
- Participate in the platform Post Launch Optimization Team meetings.
- Serve as identified responsible engineer for platform.
- Maintain a working relationship with the platform Engineering and Operation associates at the assembly sites.
- Maintain an inventory of platform assembly technology and control strategy differences across the platform.
- Drive consistency between platform assembly lines related to process risk analysis, control strategy, and assembly technology.
- Review and consult on technical studies and investigations as required.
Minimum Requirements:
- At least 10 years’ experience in the medical device, pharmaceutical, or related industry working with high speed, discrete mechanical/process assembly & packaging equipment.
- Experience with design of automated assembly machines and asset delivery.
- Demonstrated ability to influence effectively across boundaries and work in a cross-discipline team (OEMs, contract manufacturers, Lilly sites, device network, etc.).
- Working knowledge of GMPs and proficiency with risk management and process/equipment commissioning & qualification practices.
Additional Preferences:
- Automation expertise in PLC’s, robotics, and/or application of novel technology for assembly.
- Demonstrated ability to seek out and apply new technology.
Education Requirements:
Bachelor’s Degree in Engineering (or at least 11 years work experience in engineering role).
Other Information:
Travel 10-30% over the course of a year (domestic and international).
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources for further assistance. Please note this email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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