Manufacturing Engineer

Alexander Technology Group is looking for Principal Mechanical Engineer to lead the design and development of mechanical components for drug-device combination products, including material selection, biocompatibility, E&L, and human factors integration. Drive DFM/DFA, risk management (ISO 14971), and compliance with FDA/ISO standards. Qualifications & ExperienceBS in Mechanical, Materials Engineering, or related field (MS/PhD preferred)12+ years of mechanical product development experience, including 7+ years in medical devices or combination productsStrong expertise in drug-device systems, E&L, biocompatibility (ISO 10993), and human factors engineeringDeep knowledge of ISO 13485, ISO 14971, 21 CFR Part 820/Part 4, ISO 11608, and cGMPExperience leading IQ/OQ/PQ validations, design controls, FEA, tolerance analysis, and SPCProficiency in SolidWorks and PDM/PLM systemsIf interested, please send resume to