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 35,000 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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Indianapolis Device Manufacturing (IDM) organization is responsible for technical and operational support of Lilly’s medical devices and combination products. The IDM Risk Management team works across organizations to ensure a robust risk management package for each product that meets all current regulatory requirements. The team is cross functional, interfacing with device development as well as commercial manufacturing to maintain harmonization across the device network.
The Risk Management Engineer position is responsible for providing expertise in executing and maintaining control strategies and risk management business processes and tools used across the device network.
Responsibilities of this role include:
- Own and maintain local procedures, work instructions, and training associated with business tools used for control strategies and risk management.
- Provide training and technical support for Risk Management software users at IDM, DDRD, Digital Health, and Lilly manufacturing facilities.
- Partner with global and local IT to maintain risk management software applications used in IDM including acting as a liaison between the business and IT to ensure proper application of user requirements within the software.
- Provide subject matter expertise in the use of the Risk Management software. Act as liaison between Delivery Devices and Connected Solutions (DDCS), Digital Health, IDM and Lilly Device Assembly Sites during commercialization phase to provide coaching for establishing robust control strategies through the use of the Risk Management tools.
- Represent IDM as a Risk Management Process and Software SME in the Risk Management Governance Counsel and change control boards for global Risk Management tool changes.
- Ensure the proper use of the control strategy and risk management tools by performing periodic audits of the data in the different tools.
- Act as project manager and executor in tasks associated with control strategies and risk management tools.
- BS in Engineering or related technical field
- Experience with ISO14971: Medical Devices - Application of Risk Management
- Experience with complex IT tools and databases
- Experience in drug delivery systems and technologies (e.g. pre-filled and re-usable devices)
- Project Management experience
- Ability to read, interpret and apply information from global standards (ISO, AAMI, etc)
- Excellent written and oral communication skills including technical writing
- Proficient in Microsoft Excel
- Domestic and international travel may be required.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.