Sr. Principal Engineer - Delivery, Device and Connected Solutions - Eli Lilly and Company

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.

Organization Overview:

In 1992, Eli Lilly and Company established the Delivery Device business for the purpose of crafting, developing, launching, and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to deliver platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages alliances in design and manufacturing to rapidly convert proprietary concepts into products that meet the users’ needs and intended uses.

Responsibilities:

DDCS is seeking a Mechanical Design Engineer to support the design, development, and maturity of mechanical and electromechanical delivery systems to enable Eli Lilly and Company’s growing therapeutic portfolio. In this role you will be an integrated member of project teams and will be responsible for overseeing the design for assembly for existing and new delivery devices/technologies. Key responsibilities for this role include:

• Provide Mechanical/Electromechanical design engineering technical expertise, and ensure that device design concepts are based on sound design engineering principles utilizing the latest engineering tools/technologies
• Evaluation or creation of finite element analysis, tolerance stacks, manufacturing processes and scale-up, mold flow analysis, DOE, etc.
• Assess and evaluate design concepts for technical risk and DFx (manufacturability, reliability, assembly, ultrasonic welding parameters, gluing and snap fits)
• 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. This individual is responsible for ensuring detailed design risk assessments are conducted and acted upon, appropriate formal approval of associated documentation is accomplished, and all required applicable design control deliverables are completed
• Author technical reports, work instructions, change control documentation and development plans
• Demonstrate engagement and employ a quality mindset by proactively identifying quality issues and communicating appropriately

Basic 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 working in a regulated environment

Additional Skills/Preferences:

• 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

Additional Information:

• Estimated travel of up to 30% both domestic and international

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