Mechanical Engineer II
Core
Design parts, assemblies, and enclosures for Defibrillator and Ventilator products, focusing on 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 technology / Cardiopulmonary and respiratory care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical engineering design, SolidWorks (Part Design, Detailed Drawings), Engineering Change Orders, Design of Experiments (DOE), Thermal/Flow/Tolerance analysis, FMEA, Root cause analysis, Validation testing (IQ/OQ/PQ), Regulatory documentation (IEC 60601, FDA, GMP, ISO 13485)
Preferred skills
SolidWorks CSWP certification, Medical device industry experience, ASME Y 14.5 drawing standards, PDM and Simulation
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, flow, and tolerance analyses; Lead or participate in technical design reviews; Support troubleshooting and root cause investigation; Develop test plans and validation protocols.
Seniority
Mid-level IC (3-5 years experience)