Sr. Process Development Engineer– Combination Products & Device Engineer
Core
Sr. Process Development Engineer leading the development, commercialization, and lifecycle management of combination products and automated assembly technologies for auto-injectors.
Role type
Senior IC process development engineer (combination products & device assembly)
Builds
Commercial combination products, auto-injectors, and automated assembly equipment
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, process development, technology transfer, equipment validation, root cause analysis, Design of Experiments (DOE), Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), project management, cross-functional collaboration
Preferred skills
None stated
Technologies
Automated assembly equipment, GMP manufacturing systems
Responsibilities
Serve as Subject Matter Expert for combination products and device assembly; Lead development and optimization of automated assembly equipment; Execute engineering studies and characterization plans; Analyze manufacturing data for process capability; Lead product verification and performance testing; Author regulatory submissions and Design History File documentation; Manage project scope, schedules, and budgets; Mentor engineers and drive continuous improvement initiatives
Seniority
Senior, hands-on IC with technical leadership
