Systems Engineer - Medical Device, DDCS

Eli Lilly and Company • Indianapolis, IN

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About The Position

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. Organization and Position 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. This position 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 product lifecycle management across interconnected device ecosystems while delivering on current portfolio needs.

Requirements

• Bachelor's degree in an engineering or related field with 5+ years of relevant experience
• Demonstrated experience creating systems engineering work products (e.g. stakeholder requirements document, system requirements document, V&V matrices, etc.)
• Proficiency with requirements management
• Strong technical writing skills for protocols, reports, and regulatory submissions
• Experience with drug delivery devices (autoinjectors, pen injectors, wearables, inhalers) or combination products
• Knowledge of ISO 14971 (risk management), ISO 13485 (quality management), and FDA 21 CFR Part 820 (design controls)
• Experience with hazard analysis techniques (FTA, FMEA) and risk management activities
• Excellent written and verbal communication skills; able to effectively interact at all levels of the organization - business leaders, senior technical/scientific personnel, internal/external customers/suppliers/teammates
• Effective problem-solving and decision-making skills in ambiguous or complex technical situations
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Master's degree in an engineering or related field and 3+ years of relevant experience
• Experience with system modeling (SysML) and MBSE tools (Cameo, MATLAB System Composer, Capella)
• Experience with connected device ecosystems (sensors, wireless communication, mobile apps, cloud platforms)
• Understanding of multi-disciplinary system integration (hardware, software, electromechanical components)
• Familiarity with digital twin concepts and their integration with MBSE workflows
• Understanding of interoperable system design: operational independence, emergent behavior, integration strategies
• INCOSE certification (e.g. ASEP, CSEP)
• Demonstrated ability to work effectively across boundaries of cross-functional teams and influence without direct 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
• Ability to take ownership of project work and deliver according to timelines

Responsibilities

• Requirements & Traceability: Solicit, manage, and document stakeholder needs and requirements across constituent systems; perform requirements analysis, development, allocation, and management; create and maintain traceability from requirements (including system risk) to system verification and validation; manage requirements flow-down and interface requirements between constituent systems.
• Integration & Verification: Develop and document system test strategies; lead system integration, verification, and validation activities across constituent systems; participate in design reviews and contribute SE deliverables aligned with regulations and standards.
• System Design & Architecture: Develop and document system architecture including concept trade-offs, functional analysis, and interface definitions; apply systems thinking to understand how constituent systems interact within the broader product ecosystem; define and manage system boundaries and interfaces between constituent systems.
• Risk Management: Support system-level hazard identification and participate in risk identification, assessment, and management activities; collaborate on risk documentation and maintaining risk management files; apply hazard analysis techniques (FTA, FMEA) to support product safety throughout the development lifecycle.
• Continuous Improvement & Quality: Participate in the systems engineering community of practice to stay current with tools, techniques, and regulatory expectations; drive continuous process improvement focused on SE-related processes and tools; proactively identify and communicate quality issues.
• Position may require occasional support for audits, regulatory interactions, and design reviews at partner sites.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level