Senior Engineer, Device Development

Role: Lead development of complex combination products, specifically PFS/biologic vaccines, through clinical and commercial stages. Responsibilities: oversee device design, verification, and validation; ensure compliance with 21 CFR Part 4 and 820.3; develop design control documents; coordinate with cross-functional teams, suppliers, and CMO partners; support regulatory submissions and lifecycle management. Qualifications: PhD (5+ years), Masters (10+ years), or BS (13+ years) in relevant fields; extensive experience managing device development projects in a GxP environment; strong background in biologic combination products, preferably adjuvanted vaccines like pneumococcal conjugates; proven ability to lead cross-functional teams, conduct risk assessments, and execute design control processes. High-Value: biologics, combination products, prefilled syringe development, GxP manufacturing, late-stage DP development, risk management, regulatory CMC support. Location: onsite in San Carlos, CA.