Eli Lilly and Company
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Risk Management Engineer
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Eli Lilly and Company 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. 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. 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. 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. 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. 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 for further assistance. 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.
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Risk Management Engineer
role at
Eli Lilly and Company 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. 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. 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. 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. 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. 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 for further assistance. 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.
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