Mechanical Engineer II
Core
Design parts, assemblies, and enclosures for Defibrillator and Ventilator products, supporting ingress protection, flow/pneumatics, shock/vibration control, EMI isolation, and thermal management.
Role type
Mechanical Engineer II (Medical Devices)
Builds
Defibrillators, Ventilators, and related sub-systems for EMS, hospital, public safety, and military customers.
Domain
Medical Devices / Cardiopulmonary & Respiratory Care
Required skills
Mechanical design, SolidWorks (CSWP preferred), Engineering Change Orders, Design of Experiments (DOE), Thermal/Flow/Tolerance analysis, FMEA, Regulatory documentation (IEC 60601, FDA, GMP, ISO 13485)
Preferred skills
Medical device industry experience, ASME Y 14.5 drawing standards, PDM and Simulation, Root cause analysis
Technologies
SolidWorks, ASME Y 14.5, IEC 60601, FDA, GMP, ISO 13485
Responsibilities
Layout and develop new assembly and part designs; Create detailed design documentation including drawings and BOMs; Conduct design of experiments and laboratory testing; Complete engineering mechanics, thermal, and tolerance analyses; Lead or participate in technical design reviews; Support troubleshooting and root cause investigation; Develop test plans and validation protocols (IQ/OQ/PQ).