Senior Mechanical Engineer (Medical Devices)

Location: Plano, Texas, United States

Company

hirify.global is a global manufacturer of specialty medical products for interventional radiology, vascular surgery, interventional cardiology, and oncology.

What you will do

• Own mechanical product design and development from concept through launch for new and existing medical devices.
• Establish product requirements and verify conformance through inspections, functional testing, and engineering confidence testing.
• Create 3D models, detailed drawings, layouts, bills of materials, tolerance analyses, and design-control documentation.
• Perform complex FEA, DFMEA, risk analysis, mold-flow analysis, and DFM/DFA evaluations.
• Lead design reviews focused on product robustness and design for manufacture and assembly.
• Investigate materials, resolve design anomalies through root cause analysis, and coordinate prototypes and testing with vendors and the V&V team.

Requirements

• Bachelor’s degree in Mechanical Engineering and 8+ years of experience in medical devices, mechanical design engineering, and product development.
• Experience with disposable devices such as catheters or blood clot removal devices.
• Proficiency in SolidWorks, FEA, GD&T, detailed drawings, and tolerance analysis.
• Ability to apply DFM and DFA principles and conduct product risk analysis.
• Knowledge of standard laboratory test methods, experimental and statistical root cause analysis, plastics, and injection molding.

Culture & Benefits

• Work within a medical-device organization focused on improving patient outcomes through image-guided procedures.
• Collaborate with external manufacturing vendors and verification and validation specialists.