- 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.
- 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
- 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
- Domestic and international travel may be required. Less than 10%.
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Risk Management Engineer - Indianapolis, United States - Eli Lilly
Description
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:
Basic Qualifications:
Additional Preferences:
Other Information (e.g., any required certifications):
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 ( ) 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.
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