Hiring: Director, Regional Device & Drug Delivery Center of Excellence (RTC) Company: PCI Pharma Services Location: Rockford, IL Job Posted Time: 2026-09-10 11:48:36 Target Skills & Keywords : Assembly, Risk Management About the job Required Skills: •To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. •Lead translation of customer User Needs (UN) into a defined container closure and device strategy, aligned to dosing, patient population, and route of delivery. •Own Label & Packaging design activities, including DFM (Design for Manufacturability) of packaging and linkage with the Design Lab for concept development and iteration. •Direct device assembly and test process design, from concept samples through DV (Design Verification) samples. •Define and deploy scale-appropriate automation strategy, ensuring solutions are right-sized to program volume and maturity (clinical vs. commercial scale). •Establish assembly in-process control and inspection concepts to ensure consistent build quality. Oversee metrology strategy supporting lot release and regulatory submission data packages. •Drive a “Right First Time” validation philosophy, ensuring DFM interventions remove sources of variability prior to Qualification (Qual) activities. •Embed and maintain ISO 14971 risk management across the full product life cycle, from development through post-market. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!