Instrument Development Engineer

Job Description

Develop and optimize an integrated testing instrument for quality control and lot release of individualized RNA-based genetic medicines, from requirements and concept development through design, testing, and manufacturing methods. Collaborate with cross-functional teams, conduct risk analyses and compliant design documentation, support regulatory submissions, and contribute to intellectual property development.

Requirements: Requires a bachelor's degree or equivalent and directly related experience, with the hiring level ranging from 4 to 10 years for a bachelor's or 2 to 8 years for a master's. Preferred qualifications include experience designing, building, and testing novel instruments, integrating engineering subsystems, applying ISO 14971 risk management, and depth in at least two relevant technical areas.

Key Skills: Biomedical Instrument Design, Hardware Design and Fabrication, CAD, Electromechanical Design, Subsystem Integration, Bench Testing and Debugging, Risk Management, ISO 14971, Test Protocol Development, Design Documentation, Embedded Systems, Microcontroller Firmware, Optical Systems, Instrument Control Software, Python, Microfluidics