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.

Job Title: Risk Management Engineer

Organization Overview: 

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. 

Responsibilities:

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, DDCS, 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. 

Basic Requirements: 

• BS in STEM (Engineering degree preferred)
• Experience with complex IT tools and databases 
• Ability to read, interpret and apply information from global standards (ISO, AAMI, etc)
• Excellent written and oral communication skills including technical writing 

Additional Skills/Preferences:

• Experience in drug delivery systems and technologies (e.g. pre-filled and re-usable devices) 
• Familiar with ISO14971: Medical Devices – Application of Risk Management 
• Strong statistical analysis skills 
• Proficient in Microsoft Excel

Additional Information:

• Domestic and international travel may be required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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