Development Engineer, Drug-device Combination Products (ddcp)
Eli Lilly
Indianapolis, IN, US
Base: $126,000 - $204,600; bonus: eligible for com...
7+ years pharmaceutical or device development experience
Design control execution per fda 21 cfr part 820
Iso 14971 risk management and iso 13485 compliance
This role is responsible for executing design control activities and device-drug integration studies to support clinical and commercial programs at Eli Lilly
Job Summary
This role is responsible for executing design control activities and device-drug integration studies to support clinical and commercial programs at Eli Lilly.
The position requires strong technical expertise in regulatory compliance with FDA and international standards while collaborating across a diverse matrix organization.
Eli Lilly offers a comprehensive benefit program including medical, dental, vision, 401(k) matching, and flexible spending accounts alongside a competitive salary range.
Matching Summary
This role is responsible for executing design control activities and device-drug integration studies to support clinical and commercial programs at Eli Lilly.
Salary
Base: $126,000 - $204,600; Bonus: Eligible for company bonus based on performance; Benefits: Comprehensive program including 401(k), medical, dental, vision, and wellness benefits
Skills & Requirements
Must-have
7+ years pharmaceutical or device development experience
Design control execution per FDA 21 CFR Part 820
ISO 14971 risk management and ISO 13485 compliance
Device-drug integration studies and stability testing
Regulatory submission support in CTD/eCTD format
Nice-to-have
Experience with AI/ML applications in development
Lean Six Sigma process improvement skills
Strategic thinking connecting technical work to business
Cross-functional leadership within matrix organizations
Mentoring junior team members
Key Requirements
Bachelor's degree in Engineering or Pharmaceutical Sciences
7+ years of experience in pharma/biotech/device development
Familiarity with ICH guidelines and GMP/GxP requirements