Sr. Principal Engineer - Delivery, Device and Connected Solutions

Eli Lilly - Indianapolis, IN

Full-time - Senior

Indianapolis, IN

Chemical Manufacturing

About the position

The Sr. Principal Engineer in Delivery, Device and Connected Solutions at Lilly is responsible for the design, development, and maturity of mechanical and electromechanical delivery systems. This role involves providing technical expertise in mechanical design, collaborating with cross-functional teams, and ensuring that device designs meet user needs and regulatory standards. The engineer will oversee design for assembly, conduct risk assessments, and author technical documentation, all while maintaining a quality mindset.

Responsibilities

• Provide Mechanical/Electromechanical design engineering technical expertise, ensuring device design concepts are based on sound engineering principles.
• Evaluate or create finite element analysis, tolerance stacks, manufacturing processes, and mold flow analysis.
• Assess and evaluate design concepts for technical risk and manufacturability, reliability, and assembly.
• Interact with internal and external design partners.
• Work collaboratively with cross-functional teams to accelerate time to market of patient-centered designs.
• Coordinate device risk assessments and design control deliverables, ensuring compliance with documentation requirements.
• Author technical reports, work instructions, change control documentation, and development plans.
• Proactively identify quality issues and communicate appropriately.

Requirements

• Bachelor of Science in Engineering (Mechanical, Materials, or Biomedical Engineering) or a related field.
• 10+ years of experience working in industry demonstrating successful application of mechanical engineering fundamentals.
• 5+ years of Design for Manufacturability experience with a focus on design for assembly.
• 3+ years of work experience in a regulated environment.

Nice-to-haves

• 3+ years of industry experience developing drug delivery systems (e.g. cartridges, prefilled syringes, combination product delivery devices, and medical devices).
• Experience with verification and validation activities (requirements definition, tolerance stacks, first principle calculations, finite element analysis, design verification testing, and human factors).
• Experience with design control processes, including risk management and failure modes & effects analysis (FMEA).
• Ability to take ownership of project work and complete work according to project timelines.
• Technical understanding of common commercial manufacturing and assembly processes including injection molding.
• Effective application of root cause investigation, design of experiments, and statistics.
• Outstanding interpersonal skills and the ability to work efficiently in an interdisciplinary environment.
• Strong written communication skills, including technical report writing.
• Effective problem solving and decision-making skills.