Job Description:
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 purpose of this role is to provide injection molding support to the device manufacturing operations and to collaborate with all functional groups inside and outside of Lilly Indy Device Manufacturing.
Responsibilities:
Product & Production Support
- Lead joint process team, injection mold tooling and molding ancillary equipment projects.
- Provide technical injection molding expertise and guidance for validation and troubleshooting activities.
- Assure applicable regulatory and Lilly quality system requirements are met.
- Provide technical input for plastic components and assemblies to improve mold, equipment, and/or part performance for pre-filled and reusable devices.
- Work with internal & external partners to develop product and process improvements.
- Fix and determine root cause of device failures associated with injection molding and/or tooling.
- Identify strategic areas for continued process improvements.
- Coordinate activities associated with periodic mold reviews at Contract Manufacturers. Analyze results and approve documents.
- Support the implementation of Statistical Process Control for molded components.
Quality System Compliance
- Ensure quality system and regulatory compliance.
Supplier Relationship & Management
- Develop successful business relationships and integrate external project teams as needed.
- Provide assistance and oversight for injection molding, tooling, & ancillary equipment.
- Serve as a design and quality consultant to internal and external suppliers.
Compliance & Documentation
- Ensure that the work activities are conducted in accordance with applicable medical device regulations.
- Follow good quality system practices and ensure documentation is developed that supports decisions and changes.
- Review and approve validation plans, protocols, and individual mold validation summary reports to support project schedules.
Teamwork / Leadership / Communication
- Maintain frequent contact with the customers and suppliers and provide regular project updates.
- Keep customers informed and satisfied with changes through networking and communication.
- Partner regularly with others in the injection molding team to help maintain standard practices across all platforms.
Requirements
- 2+ years injection molding experience preferred.
- Understanding of medical device and/or pharmaceutical validation and other related regulatory requirements.
- Demonstrated high degree of ownership / accountability.
- Ability to work across boundaries (with equipment suppliers, Lilly manufacturing sites, parts suppliers, development team, etc).
- Excellent written and oral communication skills including technical writing.
- Ability to coordinate and prioritize multiple tasks.
- Strong attention to detail.
- Mechanical proficiency.
- Ability to work independently as well as in a team environment.
Travel Requirements:
- This role supports contract manufacturers globally. It will require travel 10-25% of the time.
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 ( [email protected] ) 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.
