Lilly IDM Product Steward in Indianapolis, Indiana
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 35,000 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.
Position Brand Description: 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.
• 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) 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.
• Participate in and support complaint investigation activities (both internal Lilly complaints and external customer complaints), and 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 Device Stewards 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 Platform Advisors on the device strategy and technical agenda to lead applicable projects.
• Participate in Design and Manufacturability reviews.
• Engineering Bachelor's Degree (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.
• Ability to drive integrated technical issues to resolution 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
• Proven ability to organize and prioritize multiple tasks
• Mechanical aptitude (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
• This role supports global device design and manufacturing and thus requires some domestic and international travel (3-4 trips per year).
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at email@example.com.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!