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 IDM Product Steward is responsible for the global product design, specifications, materials, and technical agendas for a Lilly device(s) and for providing technical support to global device manufacturing operations with interface to all functional groups inside and outside IDM (Indianapolis Device Manufacturing).

 

Specific functions, duties, or tasks:

Work with internal and external partners to develop potential 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) meetingsWrite 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.Participate 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.Participate in and support CMO Joint Process Teams to meet manufacturing objectives, as well as interface with Site TS/MS to support wet site manufacturing activities.Lead or participate 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.

Minimum Education and Experience Requirements:

Engineering Bachelor's Degree (Mechanical, Biomedical, or Electrical Engineer preferredMinimum of two years industry experience in areas which may include TSMS, Engineering, Quality, Development, Manufacturing/Packaging, or an equivalent role in a regulated environment

Additional Preferences:

Ability to drive integrated technical issues to resolution and develop and implement manufacturing operation improvementsDemonstrated high degree of ownership / accountabilityAbility 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 writingProven ability to organize and prioritize multiple tasksMechanical aptitude (ideally knowledge of mechanical equipment, controls, and validation for medical devices)Ability to work independently as well as in a team environmentExperience with CAD software packages (Solidworks, ProE, Inventor) and knowledge of current GD&T drawing practicesDeep technical expertise with device platforms, including design, materials of constructions, manufacturing process, and quality systemsStrong practical experience with Primary Loop, Operational Excellence, and Root Cause AnalysisExperience 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 skillsAbility to direct and influence technical teams with team members dispersed across multiple sites and geographies

Other 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

$64,500 - $167,200

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.

#WeAreLilly