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TS/MS Product Stewardship Engineer-IDM

Indianapolis, Indiana

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Req ID R-3246 Title TS/MS Product Stewardship Engineer-IDM City Indianapolis State / Province Indiana Country United States

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 39,000 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.

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

As a Product Steward, you will support Lilly device assembly sites and contract manufacturers globally in the manufacture of drug delivery devices, serving as the SME for the device(s) supported. You will be responsible for creating and maintaining risk management documentation (DFMEA, etc.), device specifications, and device design control documents.  Work collaboratively across the device organization, including partnering with Quality, Engineering, and Operations groups to support on-going device manufacturing, process/product improvements, CAPA, and root cause investigations is integral for this role. 

Key Objectives/ Deliverables:

  • 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.

Minimum Requirements:

  • Engineering Bachelor's Degree (Mechanical or Electrical Engineer preferred)
  • 2+ years of experience in a manufacturing environment

Additional Preferences:

  • Ability to drive integrated technical issues to resolution and develop and implement manufacturing operation improvements
  • Demonstrated high degree of ownership / accountability
  • 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
  • Proficiency in MS Excel/Word/PowerPoint
  • Ability to work across organizational and geographic boundaries (with Lilly sites, equipment and parts suppliers, vendors, contract manufacturers, and design firms
  • Previous experience in medical device manufacturing
  • 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
  • Knowledge of drug product and medical device regulatory requirements (especially cGMP, 21 CFR 820, ISO 13485, ISO 11608)

Other Information:

This role supports global device design and manufacturing, and thus requires some domestic and international travel (3-4 trips per year).

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-3246.

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.

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