Development Engineer, Drug-Device Combination Products (ddCP)

Eli Lilly and Company • Indianapolis, IN

1d • Onsite

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: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Overview: Delivery, Devices, and Connected Solutions (DDCS) sits within Eli Lilly's Product Research & Development organization. We are a diverse team of scientists and engineers responsible for discovering, designing, and developing patient-centric drug delivery solutions across a broad range of modalities — from injection devices to novel routes of administration and nanomedicines. DDCS drives the drug delivery innovation agenda across early and late development to meet the needs of an expanding portfolio that spans small molecules, biologics, and nucleic acid therapeutics. DDCS is organized around a matrix model with strong disciplinary and functional horizontals supporting innovation and commercialization verticals. Our vision is to get our medicines to more patients faster by accelerating reach and scale, guided by three strategic pillars: Delivery Systems, Robust & Sustainable, and Patient Experience + Outcomes. The Drug-Device Combination Product (ddCP) Development Engineering horizontal within DDCS bridges device platform expertise with CMC drug product development, enabling combination product submissions and launches across innovation and commercialization verticals. This team is accountable for design control execution, device-drug integration studies, and technical packages supporting Lilly's global regulatory submissions. The Development Engineer for Drug-Device Combination Products (ddCP) is a technical specialist responsible for executing design control activities, device-drug integration studies, and combination product development work to support clinical and commercial programs. Reporting to the Team Leader, Development Engineering – ddCP, this individual contributor role operates within the DDCS matrix, requiring strong technical expertise in device engineering, design controls, and regulatory compliance while building skills in cross-functional leadership, business operations, and strategic thinking.

Requirements

• Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, Materials Science), Pharmaceutical Sciences, or related technical discipline
• 7+ years of experience in pharmaceutical/biotechnology product development, medical device development, or combination product development.
• Familiarity with drug product formulation, biologics development, ICH guidelines, GMP/GxP requirements, and/or regulatory submission preparation.
• Regulatory awareness and quality mindset in GMP/GxP environments
• Excellent communication skills with ability to present technical information to diverse audiences and influence across matrix organizations without formal authority.
• Learning agility and initiative in a fast-paced, high-growth environment
• Strategic thinking that connects technical work to portfolio and business outcomes

Nice To Haves

• Master's degree in Engineering, Pharmaceutical Sciences or related discipline with 5+ years of experience as listed above, OR PhD/PharmD with 2+ years of experience as listed above
• Business acumen with interest in portfolio management, resource planning, and strategic decision-making.
• Project management experience: timeline management, resource coordination, process improvement (Lean, Six Sigma), digital tools (AI/ML, GenAI).
• Technical execution in device design controls, combination product development, and regulatory submissions
• Cross-functional collaboration within the DDCS matrix model
• Analytical rigor and data-driven problem solving

Responsibilities

• CP Risk Management & Development Strategy Conduct molecule-specific risk assessments per ISO 14971, incorporating drug product safety profiles, device failure modes, and patient use scenarios.
• Evaluate device technology platform suitability for clinical molecules considering technical feasibility, business implications, and supply chain factors.
• Perform comprehensive assessments of device options; provide data-driven recommendations considering regulatory pathway, timeline, cost, and commercial viability.
• Update risk assessments throughout product lifecycle, contributing insights to portfolio management decisions.
• Device Design Control Execution Execute molecule-specific design control activities for assigned combination product programs in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Develop and maintain molecule-specific Design History Files (DHF) including design inputs, design outputs, verification protocols, and traceability matrices.
• Author design requirements specifications incorporating drug product characteristics, delivery requirements, patient population needs, and regulatory requirements.
• Ensure DHF completeness and adequacy to support regulatory submissions and manufacturing activities.
• Integrated Control Strategy & Regulatory Readiness Develop integrated control strategies encompassing device specifications, drug product specifications, and combination product performance attributes.
• Author platform rationale documents supporting regulatory submissions across regions (FDA, EMA, PMDA, NMPA).
• Monitor regulatory landscape for combination products; partner with Regulatory Affairs to understand strategy and participate in submission planning.
• Stability Study Design, Execution & Insights Design combination product stability studies aligned with ICH guidelines and regional regulatory requirements.
• Coordinate stability programs across stakeholders; analyze data and trends to inform decisions on shelf-life, storage conditions, and 'fit for use' rationale.
• Contribute to development of stability testing strategies and organizational standards.
• Clinical Supply & Regulatory Submission Support Author technical sections for regulatory submissions (NBOp, IND, NDA, BLA, MAA) in CTD/eCTD format.
• Compile and review technical data packages; respond to regulatory questions and information requests.
• Support regulatory inspections by providing technical expertise and documentation.
• Cross-Functional Leadership & Business Operations Partner with CMC functions, Regulatory Affairs, Quality, and Manufacturing across the DDCS matrix.
• Work with device suppliers and contract manufacturers to ensure supply chain readiness for clinical trials.
• Participate in portfolio reviews, resource planning, and strategic prioritization discussions.
• Explore and pilot AI/ML applications, digital tools, and data analytics to improve development processes.
• Mentor junior team members and contribute to training programs.

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