Senior Engineer, Device Technical Operations (Hybrid)

Role: Senior Engineer in Device Technical Operations overseeing design transfer, process validation, and manufacturing support for complex medical devices and combination products such as autoinjectors, ophthalmic, and inhalation systems. Responsibilities include leveraging expertise in design controls, risk management, and verification testing to ensure product robustness, regulatory compliance, and successful technology transfer globally; supporting manufacturing issues, regulatory responses, and inspections; and fostering internal and external strategic partnerships. Qualifications: Bachelor's in mechanical, biomedical, or related engineering field; at least 5 years’ experience in pharmaceutical, biologic, or medical device engineering, with 2+ years supporting commercial manufacturing. Proven skills in design controls, risk analysis, process validation, and manufacturing operations, especially in injection molding, automation, and complex assembly for medical devices, with preference for autoinjectors or inhalation products. High-value specifics: focus on combination products with regulatory and lifecycle management responsibilities, supporting global commercialization, and ensuring compliance with ISO 13485 and ISO 14971 standards. Work setup: hybrid in the US with approximately 10% travel; role emphasizes collaboration with manufacturing, R&D, and regulatory teams to drive product quality and compliance.