Design Engineer-Delivery & Device Research and Development

Lilly is a global health care leader that unites caring with discovery to make life better for people around the world. For more than a century, we have stayed true to a core set of values—excellence, integrity, and respect for people—that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.

• Evaluation or creation of finite element analysis, tolerance stacks, manufacturing processes and scale-up, moldflow analysis, DOE, FMEA's. Experience in DFx (manufacturing, reliability, assembly, ultrasonic welding parameters, gluing, and snap fits).
• Design validation and verification activities experience with the device quality system regulation
• Coordinate device risk assessment and design control deliverables in accordance with medical device regulatory requirements (including ensuring the completion of required development phase documentation)
• Conduct meetings and prepare design-specific project presentations and reports, in addition to publishing basic schedules and participating in project problem-solving
• Partner with manufacturing, contract developers and quality to ensure robust design, testing, and design control deliverables
• Management Updates: responsible to provide design-related opinions to support the integrity of device projects for internal senior management
• Writing technical reports, work instructions, change control documentation and development plans
• Expertise in general project management skills, and a familiarity with the major steps required in technical product development, especially in a regulated environment
• Able to lead multi-functional multi-site project teams consisting of members of production, planning, quality control, marketing, as well as external design and manufacturing
• Key technical resource in development and qualification of packaging components and container closure systems for new drug substances and drug products
• Authoring and reviewing technical reports and/or regulatory submissions
• Responsible for design of experiments and interpretation of the data

• Bachelor's Degree in mechanical, materials, chemical or biomedical engineering or relevant scientific discipline.
• BS (7+ years) or MS (5+ years) in medical device, aeronautical, automotive, pharmaceutical or consumer product design, development and commercialization
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.