Development Engineer, Drug-Device Combination Products (ddCP)

Eli Lilly and Company • Indianapolis, IN

1d • Onsite

About The Position

Delivery, Devices, and Connected Solutions (DDCS) is part of Eli Lilly's Product Research & Development organization. This diverse team of scientists and engineers is responsible for discovering, designing, and developing patient-centric drug delivery solutions, including injection devices and novel routes of administration. DDCS drives drug delivery innovation across early and late development to support a wide range of products. The Drug-Device Combination Product (ddCP) Development Engineering horizontal within DDCS integrates device platform expertise with CMC drug product development, supporting combination product submissions and launches. This team manages design control execution, device-drug integration studies, and technical packages for global regulatory submissions. The Development Engineer for ddCP is a technical specialist focused on executing design control activities, device-drug integration studies, and combination product development to support clinical and commercial programs. This individual contributor role operates within the DDCS matrix, requiring strong technical expertise in device engineering, design controls, and regulatory compliance, while also developing 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

• 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.
• 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.
• 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.
• 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.
• 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.
• 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

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• 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: Senior