Job Information
Lilly Risk Management Engineer in Indianapolis, Indiana
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.
The Indianapolis Device Manufacturing (IDM) TS/MS Product Stewardship team supports the technical aspect of Lilly devices manufactured at Contract Manufacturers and Lilly sites across the world. This team supports the device product portfolio and pipeline through the development and implementation of standards for validation, technical stewardship, specification, risk management/control strategy and statistical support.
Responsibilities:
Own and maintain local and global device procedures, work instructions, and training associated with business tools used for control strategies and risk management.
Ensure global device risk management process compliance with ISO14971, supporting gap assessments and audits.
Actively represent Devices acting as SME in the Risk Management Governance Council and provide consultation during change control and CAPA review boards as needed for applicable Risk Management topics.
Provide subject matter expertise in the use of the Risk Management software. Act as liaison between DDCS and IDM during commercialization phase to ensure strategy arrangement of Risk Management tools.
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.
Act as project manager and executor in tasks associated with control strategies and risk management tools.
Basic Qualifications:
Bachelors Degree required. Degree in Engineering or related technical field preferred.
2 or more years' experience.
Demonstrated high degree of ownership / accountability
Ability to work across boundaries (Lilly Mfg sites, CMS, development team, etc.)
Excellent written and oral communication skills including technical writing
Ability to coordinate and prioritize multiple tasks
Ability to work independently as well as in a team environment
Additional Preferences:
Experience with Risk Management tools
Experience with sophisticated IT tools and databases
Strong statistical analysis skills
Experience in drug delivery systems and technologies (e.g., pre-filled and re-usable devices)
Familiar with ISO14971: Medical Devices - Application of Risk Management
Other Information (e.g., any required certifications):
- Domestic and international travel may be required. Less than 10%.
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