Risk Management Engineer

Found in: beBee jobs US - 3 weeks ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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%. 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. #WeAreLilly

  • Benefit-Risk Management Scientist

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Advisor - Engineering - IDM

    Found in: beBee jobs US - 3 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Civil Engineer

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States gpac Full time

    Come work in a dynamic environment where people are inspired to produce high quality work every day. Not only will you receive a generous PTO & benefits plan, but also a nationally recognized 401(k) retirement plan with matching and profit sharing. As a Civil Engineer, expect to plan, organize, and execute a variety of projects across both private and public...

  • AI Product Manager and Prompt Engineer

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Senior Project Manager

    Found in: beBee jobs US - 3 weeks ago

    Indianapolis, Indiana, United States Spencer Ogden Full time

    Job Summary:This position has single point accountability for the projects they are executing. They will be under the general direction of a Sr. Project Manager. This position is responsible for the management of all phases of project planning and execution to ensure all project success factors are met, including but not limited to scope, schedule, cost,...

  • AI at Lilly Product Manager and Prompt Engineer

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Construction Manager

    Found in: beBee jobs US - 3 weeks ago

    Indianapolis, Indiana, United States Mace Full time

    Position Status: This opportunity is for a secured role that is due to commence in November subject to approval. If you would like to be considered as we progress with this position, please click to apply.The OpportunityMace is seeking a full-time senior construction manager for life science and industrial manufacturing projects to work directly with our...

  • Associate Director-Capital Project Procurement

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Civil Project Engineer

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States NCW Full time

    We are looking for an experienced Civil Project Manager/Engineer for immediate hire for a civil engineering firm in Indianapolis, IN.Managing the public bid process and invoicing clients.Deliver weekly status reports to the owner, architects, developers, GC, and banks.Effectively manage QA/QC procedures and enforce project standards.B.S. in Civil Engineering...

  • Technical Writer

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Global Channel Management, Inc Full time

    Technical Writer needs instructional design, performance technology, or quantitative discipline (i.e., Sciences, Finance, Econometrics, Statistics, Engineering or Computer Sciences)Technical Writer requires:• Bachelor's degree or higher in education, instructional design, performance technology, or quantitative discipline (i.e., Sciences, Finance,...

  • Productivity Engineer

    Found in: beBee jobs US - 3 weeks ago

    Indianapolis, Indiana, United States Gvw Group, Llc Full time

    At Autocar, we deliver tools that transform the work of the people that use them, by putting our customers first.Perform all aspects of continuous improvement including but not limited to; implementing lean manufacturing practices, 5S and visual management, throughput improvements, quality improvements, safety and ergonomics, tooling and equipment...

  • Software Engineer III

    Found in: beBee jobs US - 3 weeks ago

    Indianapolis, Indiana, United States OnBoard Full time

    Title: Software Engineer III Date: Function: Engineering Reports to: Manager, Software Engineering Position Summary: The Software Engineer III will play a crucial role in the development of our SaaS applications. Leveraging your extensive experience, you will lead complex projects, mentor junior engineers, and contribute to the design of scalable and...

  • Staff Engineer, Manufacturing Engineering

    Found in: beBee jobs US - 3 weeks ago

    Indianapolis, Indiana, United States Thermo Fisher Scientific Full time

    Job DescriptionWhen you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Fisher Clinical Services, part of Thermo Fisher...

  • Network Engineers

    Found in: beBee jobs US - 3 weeks ago

    Indianapolis, Indiana, United States CyberGuard Solutions Full time

    CyberGuard Solutions is a fast-growing technology services company with client projects that involves new and exciting technology areas and solving challenging business problems. Our domains include a broad range of technology areas (SIEM and Cyber security tools Mobile development) data analytics and advisory work on process improvements and outsourcing...

  • Senior Project Manager

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Mace Full time

    Position Status: This opportunity is for a secured role that is due to commence in October subject to approval. If you would like to be considered as we progress with this position, please click to apply.The OpportunityMace is seeking a full-time senior project manager for life science and industrial manufacturing projects to work directly with our clients...

  • AI Data Engineer

    Found in: beBee jobs US - 1 week ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Civil/Structural Engineer

    Found in: beBee jobs US - 3 weeks ago

    Indianapolis, Indiana, United States P&C Recruiting | HR Full time

    As a Civil/Structural Engineer, reporting to the Civil/Structural Engineering Manager, you will have the opportunity to: Description: Design civil/structural systems, structures, and components Assist with modifications to existing equipment, systems, structures, and components Provide technical support to various divisions Assist with project planning and...

  • Automation Engineer

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Packaging Engineer

    Found in: beBee jobs US - 3 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Sr. Automation Engineer

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...