Mechanical Engineer - 6 Month Fixed Term Hire
Core
Lead the design, development, and optimization of neuro-lead interfaces and implantable medical devices for a closed-loop neuromodulation platform.
Role type
Senior IC mechanical engineer (implantable medical devices)
Builds
Implantable medical devices and neuro-lead interfaces
Domain
Medical devices / Neurology / Implantable electronics
Required skills
Mechanical design, 3D modeling, rapid prototyping, FDA regulations (21 CFR 820.30), IEC 60601-1 standards, risk management, device history file creation, regulatory filing support, intellectual property development, manufacturing design transfer
Preferred skills
Labelling experience
Technologies
3D modeling software, rapid prototyping tools
Responsibilities
Lead design and optimization of neuro-lead interfaces and implantable devices; Collaborate with R&D, engineering, and clinical teams; Utilize 3D modeling and rapid prototyping for design iterations; Document designs for verification and validation; Lead sub-projects and collaborate with external manufacturing teams; Compile and analyze operational data to establish technical specifications; Develop device history files including requirements, risk management, and usability files; Support regulatory filings and intellectual property development
Seniority
Mid-level, hands-on IC