Platform Systems Engineer

In 1992, Eli Lilly and Company established the Delivery, Device, and Connected Solutions (DDCS) business for the purpose of creating, 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 delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. This business enables almost $4.0 billion in pharmaceutical sales and is projected to double in the next 6 years.

Are you seeking a career that makes a difference in the world? Are you motivated by improving time to market, cost, product quality, product line scalability, and productivity thru platform systems engineering? We are seeking a highly motivated systems thinker with expertise in Platform or Product Line Engineering to join our DDCS team. The DDCS Platform System Engineer is a key technical member of multi-functional teams comprised of various technical and functional disciplines such as Electrical, Mechanical, Human Factors, and Materials Engineering, as well as Medical, Marketing, Regulatory, Quality, Manufacturing, and Global Patient Safety. They develop capabilities across multiple, complex systems to provide seamlessly integrated device and combination product solutions. Key responsibilities include the following:

• Responsible and accountable for system level design inputs, outputs, risk and evidence throughout the development process
• Create, maintain, manage, and evolve a portfolio of related combination product(s) platform / product line through each stage of the development life cycle with a particular focus on system requirements, risk, architecture, and test
• Drive continuous process improvement, with an emphasis on systems engineering and platform / product line engineering related processes
• Provide platform systems engineering related coaching, mentoring, and training to colleagues and team members

Company Overview

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 39,000 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

Basic Qualifications

• Bachelor's Degree in an Engineering, Math, Computer Science, or Physics field
• 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

Additional Information

• Location is at Lilly Technology Center - North, Indianapolis, IN
• Ability to travel up to 10% of the time both domestic and international
• Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Additional Skills/Preferences

• Master's Degree
• 2+ years engineering experience within a regulated industry
• Experience in Product Line Engineering (PLE or 2GPLE) methodologies, approaches, and tools as well as familiarity with ISO/IEC 26550
• Experience with FDA class II or III medical device regulatory requirements with knowledge of drug product and medical device standards (i.e. cGMP, 21 CFR 820, ISO 13485, IEC 60601, ISO 11608, ISO 14971, IEC 62366, etc…)
• Demonstrated experience and in depth knowledge of systems engineering including but not limited to requirements elicitation / development / traceability / management / allocation, interface definition and management, system architecture development, enterprise architectures, technical planning and risk assessments, system level risk assessments (patient safety), trade-offs, system modeling and simulation, system integration, verification and validation planning and execution, model-based systems engineering (MBSE)
• Demonstrated ability to lead multi-functional teams, reach across boundaries, and effectively influence without authority to drive organizational culture change
• Excellent written and verbal communication; able to establish and maintain strong working relationships with all levels of the internal organization across multiple functions and disciplines as well as with external suppliers, stakeholders, partners; capable of translating complex technical information into management level communications
• INCOSE certified Systems Engineering Professional (ASEP, CSEP, ESEP)