Senior Engineer, Device Development
Core
Lead development of combination products (specifically pre-filled syringe/biologic combinations) through clinical and commercial stages, ensuring regulatory compliance and technical execution.
Role type
Senior Engineer, Device Development (Combination Products)
Builds
Pre-filled syringe (PFS) combination products for clinical and commercial use
Domain
Biopharmaceuticals / Vaccine Development / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Combination product design control, Design History File (DHF) and Device Master Record (DMR) management, cross-functional matrix leadership, supplier and lab management, regulatory CMC strategy, risk assessment, process validation, GxP manufacturing knowledge
Preferred skills
Adjuvanted vaccine experience, pneumococcal conjugate vaccine experience, late-stage DP development, PPQ protocol execution, suspension drug product manufacturing
Technologies
21 CFR Part 4, 21 CFR Part 820.3, GxP environments
Responsibilities
Lead combination product and device development activities through clinical development, tech transfer, commercial manufacturing, registration, launch, and post-market surveillance; Guide the DP Technical Team on technical/CMC requirements for compliance; Develop and maintain design control documents and regulatory documentation; Collaborate with cross-functional teams to execute device-specific plans; Manage suppliers, device testing labs, and Human Factors Engineering partners; Support tech transfer activities to CMOs; Contribute to device-related submission strategies; Mentor other engineers
Seniority
Senior, hands-on IC with mentorship responsibilities
