IDM Product Steward

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 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.

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.

This role will serve as Product Steward responsible for the global product design, specifications, materials, and technical agendas for one or multiple Lilly devices and for providing technical support to global device manufacturing operations with interface to all functional groups inside and outside IDM.

Responsibilities:

Work with internal and external partners to develop product and process improvements. Develop project alternatives to meet technical support needs, assisting in assessment and selection of improvement projects. Provide change control ownership and support. Responsible for design control, validation and verification activities, and manufacturing control strategy. Develop specifications, protocols, sampling plans, engineering studies, technical reports, organize and facilitate Failure Modes, and Effects Analysis (FMEA) meetings Write technical reports, validation plans, inspection procedures, test procedures, work instructions, change control documentation, deviations, development plans, internal contracts, device master record, and quality control plans. Lead or participate on multi-functional project teams consisting of internal functional support as well as external design and manufacturing resources. Provide support to product lifecycle management and monitoring processes such as PLRMR and GPA. Assist in and support complaint investigation activities (both internal Lilly complaints and external customer complaints), recommend product and/or process improvements as needed to address these complaints, and support maintenance and review of technical reports supporting common response language. Assist in and support CMO Joint Process Teams to meet manufacturing objectives, as well as collaborate with Site TS/MS to support wet site manufacturing activities. Lead or assist in root cause investigation teams to develop and implement corrective and preventative actions that address design and manufacturability concerns. Interface with the IDM Device GPLOT on the device strategy and technical agenda to lead applicable projects. Participate in Design and Manufacturability reviews. Basic Qualifications: Bachelor's Degree required (Mechanical or Electrical Engineer preferred) Minimum of two years industry experience in areas which may include TSMS, Engineering, Quality, Development, Manufacturing/Packaging, or equivalent experience required. Additional Skills/Preferences: Ability to drive integrated technical issues to completion and develop and implement manufacturing operation improvements Demonstrated high degree of ownership / accountability Ability to work across organizational and geographic boundaries (with Lilly sites, equipment and parts suppliers, vendors, contract manufacturers, and design firms) Excellent written and oral communication skills including technical writing Ability to organize and prioritize multiple tasks Mechanical proficiency (ideally knowledge of mechanical equipment, controls, and validation for medical devices) Ability to work independently as well as in a team environment Experience with CAD software packages (Solidworks, ProE, Inventor) and knowledge of current GD&T drawing practices Deep technical expertise with device platforms, including design, materials of constructions, manufacturing process, and quality systems Strong practical experience with Primary Loop, Operational Excellence, and Root Cause Analysis Experience with manufacturing operations (ideally discreet manufacturing and/or high speed assembly operations) Knowledge of drug product and medical device regulatory requirements (especially cGMP, 21 CFR 820, ISO 13485, ISO11608) Demonstrated project management abilities and excellent written and oral communication skills Ability to direct and influence technical teams with team members dispersed across multiple sites and geographies Additional Information: Domestic and international travel may be required. 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

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