Principal Assembly Process Engineer

Eli Lilly and Company • Indianapolis, IN

10d • Hybrid

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 Overview: The Delivery, Device, and Connected Solutions (DDCS) organization at Eli Lilly and Company supports the design, development, and commercialization of drug products and pharmaceutical delivery systems—including medical devices, combination products, container closure systems, and connected/digital health devices. Within DDCS, the Embedded Systems and Process Engineering (ESPE) group drives engineering capability across the full product lifecycle, from early concept development through global commercial manufacturing. ESPE is responsible for building and sustaining the assembly process engineering, automation, and embedded systems capabilities that enable Lilly’s next-generation delivery platforms to achieve reliable, scalable, and regulation-compliant production. This role supports assembly process development across the full spectrum of DDCS delivery platforms, including but not limited to: Subcutaneous injection: autoinjectors, pen injectors, wearable injectors, and prefilled syringes (primary modality) Transdermal delivery: patch systems and microneedle arrays Connected/digital health devices: IoT-enabled delivery systems with onboard electronics and sensors Container closure systems: prefilled syringes, cartridges, vials, and associated closures Position Overview: The Principal Assembly Process Engineer serves as a senior technical authority and process development leader within the DDCS Embedded Systems and Process Engineering (ESPE) group. This role is accountable for building and advancing assembly process engineering capabilities across Lilly’s drug delivery device portfolio—leading process development activities, establishing engineering best practices, and guiding cross-functional teams through the design, development, and scale-up of automated and semi-automated assembly processes for combination products and medical devices. The incumbent partners closely with Device R&D, Indianapolis Device Manufacturing (IDM), Equipment Development Group (EDG), Commercialization Technology Center (CTC), and external OEMs and system integrators to ensure that assembly processes are technically sound, scalable, and compliant with applicable regulatory standards. The role combines deep individual-contributor technical expertise with informal leadership across project teams and may include management of a small number of direct reports.

Requirements

• Bachelor of Science in Engineering (i.e. Mechanical, Manufacturing, Biomedical, Industrial, Chemical, etc.), or closely related discipline.
• 10+ years of combined relevant process development and assembly engineering experience
• Demonstrated expertise in assembly process development for medical devices, combination products, or comparable highly regulated manufacturing environments.
• Experience with process FMEAs, risk management frameworks (per ISO 14971), and process/equipment commissioning, qualification, and validation (CQV) in a design-controlled environment.
• Familiarity with FDA 21 CFR Part 820 Design Controls, ISO 13485 quality management systems, and applicable ASME V&V 40 principles for computational evidence supporting device manufacturing decisions.
• Working knowledge of automated assembly systems including PLC-based controls, robotics, vision systems, and part handling/feeding systems as applied to device assembly equipment.

Nice To Haves

• Master’s degree in a relevant engineering discipline with 7+ years of experience OR a PhD with 5+ years of experience as listed above.
• Advanced degree (MS or PhD) in a relevant engineering discipline.
• Experience in the medical device or combination product industry, particularly under ISO 13485 quality systems.
• Experience with Design for Assembly (DFA) / Design for Manufacturability (DFM) in high-speed discrete assembly contexts.
• Experience leading technical teams or cross-functional project teams in a matrixed environment.
• Familiarity with specific automation platforms (e.g., Beckhoff TwinCAT, Siemens TIA Portal, Allen-Bradley/Rockwell, Cognex vision, FANUC/ABB robotics).
• Experience with digital twin frameworks, virtual commissioning, or simulation-based process development (e.g., Tecnomatix, Visual Components, or equivalent).
• Exposure to Industry 4.0 concepts: IIoT sensor integration, edge computing for process monitoring, or machine learning–driven process control.
• Working knowledge of computational modeling tools (FEA, CFD) as applied to joining process simulation or assembly fixture optimization.
• Experience with high-speed packaging or assembly lines in pharmaceutical, medical device, or comparable regulated manufacturing.
• Publications, patents, or conference presentations in assembly engineering, automation, or process development.

Responsibilities

• Process Development Leadership Serve as the primary technical authority for assembly process development within DDCS ESPE, establishing the scientific and engineering foundation for joining technologies, part handling, and automated assembly across device platforms.
• Lead design, development, and optimization of assembly processes for drug delivery devices and combination products, spanning adhesive bonding, ultrasonic welding, laser welding, snap-fit assemblies, and mechanical joining methods.
• Establish and enforce Design for Assembly (DFA) and Design for Manufacturability (DFM) principles early in product development programs, influencing device design to ensure compatibility with automated assembly at production scale.
• Champion statistical rigor in experimental design (DOE), gauge repeatability and reproducibility (GR&R), and process capability studies (Cpk/Ppk) to build data-driven process understanding.
• Drive development of process flow documentation, assembly process specifications, and related technical deliverables to support program execution and regulatory submissions.
• Lead and standardize process development systems, tools, and best practices in partnership with DDCS and IDM subject matter experts.
• Technology Development and Innovation Identify, evaluate, and advance assembly process technologies to improve process robustness, capital efficiency, and time-to-volume across the DDCS portfolio.
• Profile and prioritize emerging assembly technologies—including advanced joining methods, vision-guided robotics, and AI-augmented process monitoring—against current and future DDCS program needs.
• Lead proof-of-concept and de-risking studies for novel assembly processes, part handling methods, and automation approaches in the Innovation Technology Center (ITC) and with external partners.
• Design and implement lab-scale equipment and fixtures to evaluate new assembly processes and part handling solutions; translate successful concepts into scalable manufacturing specifications.
• Develop business cases for the application of new technology to DDCS commercialization platforms, including cost-benefit analyses and risk assessments.
• Engage with external professional organizations, academic partners, and industry consortia to maintain awareness of leading and emerging assembly, automation, and process technology.
• Platform and Commercialization Support Provide focused technical support to platform teams and commercialization programs, ensuring assembly processes are robust, validated, and aligned with regulatory expectations.
• Perform Design for Manufacturability reviews; consult with and influence Device R&D to develop component designs compatible with automated assembly requirements and production scale.
• Lead or support generation of user requirements, process FMEAs, Comprehensive Hazard Analyses (CHA), and control strategies for assembly processes and equipment.
• Support OEM selection and provide technical oversight of outsourced process and equipment development, including review of equipment design documentation and factory acceptance testing.
• Maximize equipment fungibility—designing and specifying assembly solutions capable of supporting multiple device platforms and product generations.
• Support troubleshooting of assembly yield, throughput, and process variability issues across development and commercial manufacturing operations.
• Cross-Functional and External Engagement Build and leverage a strong technical network to advance assembly engineering capabilities across the organization and external ecosystem.
• Provide technical leadership and guidance to cross-functional project teams, serving as the assembly process engineering voice throughout product development and scale-up.
• Assess technical capabilities of OEMs and system integrators; ensure external solutions align with Lilly design controls, quality agreements, and engineering standards.
• Maintain productive relationships across DDCS, IDM, EDG, CTC, contract manufacturers, and global device network manufacturing sites.
• Serve as subject matter expert in technical studies, design reviews, regulatory interactions, and investigations as required to support project delivery.
• People Development and Knowledge Transfer Contribute to the growth of assembly engineering talent and institutional knowledge within DDCS.
• May manage a small number of direct reports; responsible for coaching, development planning, and performance management.
• Mentor engineers and interns with particular focus on process development fundamentals, statistical methods, and assembly engineering best practices.
• Support development of broader DDCS and device network technical capabilities through training, documentation, and knowledge sharing.
• Identify and help mitigate technical capability gaps within the ITC and ESPE team.
• Health, Safety, Environmental (HSE) and Quality Ensure compliance with safe execution of ITC activities, including Lilly policies such as Lock Out Tag Out (LOTO), Equipment Specific Instructions (ESI), and equipment design standards.
• Embed HSE considerations into equipment and process design, maintenance activities, and lab operations.
• Demonstrate and foster a quality mindset—proactively identifying quality issues, communicating appropriately, and ensuring assembly processes and technologies are designed to minimize risk and variability.
• Ensure compliance with applicable regulations and standards including ISO 13485, ISO 14971, 21 CFR Part 820, and applicable equipment and process validation requirements.

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