Mechanical Engineer II - Sustaining
Core
Design parts, assemblies, and enclosures for Defibrillator and Ventilator products while supporting sustaining engineering efforts.
Role type
Mechanical Engineer II (Sustaining)
Builds
Defibrillator and Ventilator product lines
Domain
Medical devices (cardiopulmonary/respiratory)
Deliverable
production ML models | product features
Required skills
Mechanical design, engineering mechanics analysis, thermal/flow analysis, tolerance analysis, SolidWorks (Part Design, Detailed Drawings), ASME Y 14.5, design documentation, FMEA, root cause analysis, test plan development, validation testing
Preferred skills
Medical device industry experience, IEC 60601, FDA, GMP, ISO 13485 knowledge, SolidWorks CSWP certification
Technologies
SolidWorks, ASME Y 14.5
Responsibilities
Layout and develop new assembly and part designs; Complete engineering mechanics, thermal/flow, and tolerance analysis; Create detailed design documentation and Engineering Change Orders; Support test and regulatory submission document preparation; Lead and participate in technical design reviews; Lead or support troubleshooting and root cause investigation; Present new designs to suppliers and evaluate prototypes; Develop test plans and validation protocols; Conduct verification and validation testing; Perform statistical analysis and data evaluation
Seniority
Mid-level, hands-on IC
