Eli Lilly and Company

Senior Systems Engineer-Delivery and Device

Location
Indianapolis, IN
Posted
Oct 31, 2018
Ref
45617
Required Education
Bachelors Degree
Position Type
Full time
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.

Responsibilities
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.

We are seeking an experienced and innovative Systems Engineer (SE) to join our DDCS SE team. The ideal candidate exhibits an exceptional degree of ingenuity, creativity, and resourcefulness and is viewed as a Systems Engineering technical expert. Lilly DDCS Systems Engineers are key technical leaders of multi-functional teams comprised of various technical and functional disciplines such as Software, 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 and system of systems to provide seamlessly integrated connected device solutions. Key responsibilities include the following:
  • Responsible and accountable for system level design inputs, outputs, risk and evidence throughout the development process
  • Elicit needs and requirements from stakeholders; create, allocate, and manage system requirements; collaborate with technical functions to create subsystem and interface requirements
  • Create and manage requirements traceability to system risk, verification and validation
  • Design/develop system architectures that incorporate flexibility, adaptability, modularity, and scalability to maximize reuse and interoperability / integration
  • Identify system hazards and perform system risk identification, assessment, and management
  • Develop, coordinate, and document the system test strategy and lead system integration, verification, and validation activities
  • Provide guidance, coaching, mentoring, and / or training to Systems Engineers, Technical Leads, and other Engineering and/or Functional staff
  • Drive continuous process improvement, with a specific focus on systems engineering related processes
  • May act as a Technical Lead on complex programs serving as the single point of technical accountability for successful delivery of the technical solution.
45617BR

Basic Qualifications
  • Bachelor's degree in Engineering, Math or Computer Science with 10 years of work experience OR
  • Master's degree in Engineering, Math or Computer Science with 8 years of work experience OR
  • PhD in Engineering, Math or Computer Science with 3 years of work experience


Additional Skills/Preferences
  • 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...)
  • Prior leadership or supervisory experience managing complex programs, systems engineering tasks, or multi-functional teams; works effectively across boundaries, effectively influences without authority, excels in a highly collaborative environment
  • 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)
  • Previous organizational change management experience
  • Familiar with one or more requirements, architecture, and/or MBSE software tools and experience in both structured (i.e. waterfall) and iterative (i.e. Agile) development methodologies
  • 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 executive level communications
  • INCOSE certified Systems Engineering Professional


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 credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. Here are a few of the recognitions Lilly has earned for creating an outstanding work environment:
  • Business Week magazine 50 Best Places to Launch a Career
  • Black Enterprise 2018 list of 50 Best Companies for Diversity
  • FORTUNE 50 Best Companies for Minorities
  • Human Right Campaign Corporate Equality Index - 100% score
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.