Systems Engineer - Medical Device

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.

Position:  Systems Engineer, DDCS

Location: Lilly Technology Center-North (LTC-N)

Overview:

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.

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.

Position Summary:

As a Systems Engineer, you are a key member of multi-functional teams comprised of other technical disciplines (Software, Electrical, Mechanical, Materials, etc.) as well as Medical, Marketing, Regulatory, Quality, Manufacturing, and Global Patient Safety. You will integrate all technical disciplines and functions into a team effort throughout the structured development process. Defining the requirements and architecture of the system (the “pieces” and how they interact), the performance and functional requirements of the system (what the system must be capable of doing and how well), system risk, and the integration and test (verification and validation) of the overall system are major components to this role.

Responsibilities:

• Responsible and accountable for system level design inputs, outputs, risk and evidence throughout the development process

• Work with technical leads to drive consistency when developing, managing, and documenting stakeholder needs and requirement

• Perform, create, and manage system requirements including but not limited to requirements analysis, development, and allocation

• Create and manage traceability from requirements (including system risk) to system verification/validation

• Develop and document system architecture, including preliminary concept development trades-offs and system functional analysis

• Identify system hazards and perform system risk identification, assessment, and management

• Develop and document the system test strategy and lead system integration, verification, and validation activities

• Participate in the internal systems engineering community of practice to keep abreast of relevant systems engineering tools and techniques (literature / technologies / capabilities / regulatory) to optimize project, team, and individual performance

• Drive continuous process improvement, with a specific focus on systems engineering related processes.

• Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately.

Basic Requirements:

• Bachelor’s degree in a Science, Technology, Engineering, or Math (STEM) field

• Experience in Systems Engineering in a regulated industry, or experience working on medical devices

• 2+ years of work experience, relevant internships will be considered
   

Additional Preferences:

• Demonstrated ability to lead multi-functional teams, work effectively across boundaries, and to effectively influence without authority

• Strong collaboration skills and ability to work productively in an interdisciplinary environment

• Broad, integrated technical knowledge for system and design engineering, product development, and commercialization in a highly regulated environment

• Excellent written and verbal communication skills, able to effectively in