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Process Engineer-IDM

Indianapolis, Indiana

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Req ID R-1822 Title Process Engineer-IDM City Indianapolis State / Province Indiana Country United States

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.

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.  IDM leverage external partners to produce medical device sub-assemblies.  Process Engineers in IDM work with Contract Manufactures to help ensure the efficient and reliable supply of medical device sub-assemblies.  In addition Process Engineers in IDM work with Original Equipment Manufactures (OEM) to design and build custom medical device assembly machines.

Key Objectives/ Deliverables:

  • Provide technical oversight for production processes for which they are responsible, ensuring stable supply of devices, subassemblies and components to Lilly sites.
  • Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability
  • Support 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 project
  • Define and mitigate technical and patient risks, including use of FMEA
  • Assure each design includes maximum appropriate re-use of technology from prior projects
  • Oversee OEM's design process, assuring questions are resolved and barriers to progress are removed
  • Conduct thorough design reviews to assure design meets requirements and local/corporate standards
  • Characterize unit operations and set operating conditions as required by defining an Engineering Studies plan, developing rigorous studies and executing them
  • Assure testing is appropriately developed and is in accordance with the risk level of the item being tested
  • Document research and investigations as technical reports
  • Complete 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.
  • Support/lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.
  • Support the timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
  • 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.   
  • Ensure timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
  • Lead prioritization of process and product changes necessary to maintain, sustain and improve the manufacturing process.
  • Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda.
  • Develop effective and productive working relationships with colleagues at CM sites.
  • Lead cross-functional/cross-site/cross-company project teams as needed.
  • Influence Commercialization project teams for new devices with focus on manufacturing readiness.
  • Identify and implement process and product changes necessary to maintain, sustain and improve the manufacturing process.
  • Support Technical Stewardship projects to improve device design.
  • Develop effective and productive working relationships with colleagues at CM sites.

Minimum Requirements:

  • BS in an Engineering or Engineering related field
  • Minimum 2 years engineering experience, preferably in Manufacturing

Additional Preferences:

  • Medical Devices experiences preferred
  • Experience with DOE and statistical methods as applied to engineering studies and reports
  • Experience in large capital project delivery and management of sub-projects within a larger project
  • Demonstrated high degree of ownership / accountability
  • Strong communication, teamwork, and networking skills
  • Mechanical Aptitude
  • Solid technical writing skills
  • Proven ability to organize and prioritize multiple tasks
  • Strong attention to detail
  • Proven problem solving skills
  • Ability to work independently as well as in a team environment

Other Information:   Ability to travel 25% on average with peak over 50% for a few months at a time

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help 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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-1822.

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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