Senior Scientist, Combination Product Characterization (Onsite)

Role: Senior Scientist specializing in device characterization and design for combination products, focusing on pre-filled syringes and auto-injectors. Objectives include identifying device risks, improving performance, and supporting pipeline development through advanced analytical techniques and in silico modeling. Responsibilities encompass lab-based testing, troubleshooting, designing experiments, developing proof-of-concept prototypes, and collaborating cross-functionally with QA, analytical sciences, and external vendors. Qualifications: B.S., M.S., or Ph.D. in Mechanical Engineering, Material Science, or related field; 4+ years (MS) or 6+ years (B.S.) experience in device design, testing, and development; expertise in optical imaging, mechanical testing, CAD (SolidWorks), FMEA, and risk management in regulated environments. Preferred skills include familiarity with medical device standards (ISO 13485, ISO 14971), design controls (21 CFR 820.30), and experience with device software standards, regulatory guidance, and industry standards like ISO 11040 and ISO 10993. High-value details: Focus on combination device development within regulated, GxP environments, emphasizing device reliability, failure mode analysis, and cross-functional teamwork. The role is based in the US/Canada without travel requirement.