Principal Engineer - Computer-Aided Engineering; DDCS

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.

• Develop, execute, and interpret in silico models to support device development, design optimization, and technical risk mitigation across early- and late-phase programs.

• Build reusable simulation frameworks, material libraries, and standardized workflows to improve efficiency and consistency.

• Communicate modeling assumptions, methods, and results to cross‑functional stakeholders, including non‑technical audiences.

• Author and review technical reports and regulatory submission content (IND/CTX, CTD) related to computational modeling.

• Define physical testing requirements in collaboration with internal teams and external partners to support model input and validation activities.

• Manage external vendor relationships for modeling support and component design evaluation.

• Evaluate emerging simulation methodologies, regulatory expectations, and industry practices; recommend and implement relevant advancements.

• Contribute to model governance and credibility assessment frameworks aligned with ASME V&V 40.

• Collaborate with cross‑functional teams, including Formulation Science, Device Engineering, Quality, Regulatory, and Manufacturing.

• Maintain a quality mindset by identifying issues proactively and supporting continuous improvement.

• MS in Mechanical Engineering, Biomedical Engineering, Computational Mechanics, or related field with 3+ years of Finite Element Analysis (FEA) experience.

• Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

• Expertise in commercial FEA solvers (e.g., Abaqus, ANSYS), including nonlinear analysis, contact mechanics, and material modeling (hyperelastic, viscoelastic, plasticity).

• Proficiency in preprocessing tools (e.g., Hyper Mesh) and scripting languages (Python, MATLAB, or solver‑native).

• Working knowledge of ASME V&V 40 and FDA guidance on computational modeling for medical devices.

• Familiarity with medical device design controls (ISO 13485, 21 CFR Part 820).

• Experience with multiphysics simulation (e.g., COMSOL, Ansys Fluent).

• Exposure to ML/AI applications in simulation (surrogate modeling, design space exploration).

• Familiarity with model‑based systems engineering, digital twin concepts, or uncertainty quantification methods.

• Knowledge of materials and components common to pharmaceutical delivery systems (injection‑molded plastics, elastomers, glass/polymer containers, spring mechanisms).

• Experience with design for manufacturing principles.

• Strong technical writing and verbal communication skills.

• Ability to manage multiple projects and deliver against timelines with minimal oversight.

• Effective problem‑solving and decision‑making capabilities.

• Collaborative approach in interdisciplinary team environments.

• Travel:
  Up to 10 % (domestic and international).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you…