Manufacturing Engineer
Alexander Technology Group
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 & Experience
- BS 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 products
- Strong expertise in drug-device systems, E&L, biocompatibility (ISO 10993), and human factors engineering
- Deep knowledge of ISO 13485, ISO 14971, 21 CFR Part 820/Part 4, ISO 11608, and cGMP
- Experience leading IQ/OQ/PQ validations, design controls, FEA, tolerance analysis, and SPC
- Proficiency in SolidWorks and PDM/PLM systems
If interested, please send resume to View email address on click.appcast.io
Vacancy posted 4 days ago
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