Organization Overview:The Delivery, Device, and Connected Solutions (DDCS) organization within Eli Lilly and Company supports the design, development, and commercialization of drug products and pharmaceutical delivery systems, including medical devices, device constituents of combination products, and container closure systems.
The Advisor - Systems Engineer within DDCS serves as a key member of multi-functional teams, integrating technical disciplines (Software, Electrical, Mechanical, Materials, etc.) as well as Medical, Marketing, Regulatory, Quality, Manufacturing, and Global Patient Safety throughout the structured development process.
As the systems engineering function evolves, this role will contribute to building advanced capabilities in Model-Based Systems Engineering (MBSE), digital thread, and interoperable system approaches to further enable traceability, risk management and efficient medical device product lifecycle management across interconnected device ecosystems while delivering on current portfolio needs.
Key Responsibilities:- Requirements & Traceability: 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.
- System Design & Architecture: Responsible and accountable for system level design inputs, outputs, risk, and evidence throughout the development process; design/develop system architectures that incorporate flexibility, adaptability, modularity, and scalability to maximize reuse and interoperability/integration, applying cross-functional and external technical knowledge to drive data-driven architecture decisions.
- Integration & Verification: Develop, coordinate, and document the system test strategy and lead system integration, verification, and validation activities.
- Risk Management: Identify system hazards and perform system risk identification, assessment, and management; independently identify critical systems engineering issues affecting program delivery and proactively manage risk with an end-in-mind approach to minimize schedule and scope impact.
- Leadership & Mentoring: Provide guidance, coaching, mentoring, and/or training to Systems Engineers and Technical Leads within their function or program team; may support a Technical Lead role on complex programs, contributing to technical accountability for successful delivery of the solution.
- Collaboration & Inclusion: Build and sustain a diverse, cross-functional and external network - spanning technical, clinical, regulatory, and business disciplines - to bring forward the best ideas and create an environment where team members feel safe to contribute.
- Continuous Improvement & Quality: 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 Qualifications:- Earned Bachelor's degree in a Science, Technology, Engineering, or Math (STEM) field
- 10+ years of relevant experience
- Demonstrated experience and in-depth knowledge of systems engineering in one or more of the following areas: 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)
- Experience in systems engineering specifically with regard to medical devices or combination products
- 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
Additional Preferences:- Advanced degree in a Science, Technology, Engineering, or Math (STEM) field
- 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.)
- 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
- INCOSE certified Systems Engineering Professional
- Familiar with, or experience creating medical devices as a platform.
- 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
- Previous organizational change management experience
Other Information:- This is a hybrid position, working within the Indianapolis Tech Center North location and will require 3 days of in-office work presence.
- Minimal travel (less than 5%) is needed for this role
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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