Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)

Role: Associate Principal Scientist leading testing strategies for drug–device combination products within the Device Development & Technology team. Responsibilities: define and execute design verification strategies, develop and validate test methods, oversee aging studies, support validation activities, and ensure regulatory compliance across product lifecycle stages. Collaborates extensively with cross-functional teams and external partners to align testing with development, manufacturing, and regulatory goals. Qualifications: B.S., M.S., or Ph.D. in Mechanical Engineering or related field, with 3–8+ years of experience in combination product development, particularly in device design verification, risk management, and validation. Requires strong knowledge of regulatory standards (e.g., ISO 11608, 11040, 13485, 14971), expertise in materials testing, design controls, and manufacturing validation. Preferred skills include experience with various materials (plastics, metals, elastomers), device sub-assemblies, failure analysis, CAD (SolidWorks), rapid prototyping, and industry standards. High-value specifics: focus on biologic/drug/vaccine combination products, with exposure to inhalation, implantation, and injection delivery routes, supporting clinical and commercial phases. The role involves 25% travel, reports into senior leadership, and is based in a hybrid or onsite setting.