Company Overview:
Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.
Position Overview:
The Sr. Mechanical Engineer performs and owns all aspects of new and existing medical device product design, drawing, development, costing, manufacturability, optimization, Engineering confidence testing, packaging, and design control documentation with adherence to all applicable standards from conception to launch.
What you will do:
• Establishes requirements and assures product conformance through appropriate inspection and test activities.
• Review product / system requirements and create new concepts for mechanical design of new product or enhance the design of existing product as required and own the development process from concept to launch.
• Develop mechanical design to product specifications in compliance with company standards, procedures, specifications, and codes.
• Design and develop tolerance stack analysis using 3D modeling and statistical tools. Support the design control process with necessary documentation like DFMEA, Impact analysis.
• Prepares layout and detailed drawings including all required fits, dimensions, section views and parts lists/BOM
• Conduct complex FEA, as needed, to ascertain the design conforms to the functional and safety requirements.
• Conduct complex DFMEA and develop design controls to mitigate the product level risk.
• Investigate new materials and incorporate complex DFM and DFA principles into product design
• Perform mold flow analysis to ascertain the part design accommodates all injection molding process requirements.
• Lead design reviews for systems robustness and Design for Manufacture and Assembly (DFMA)
• Perform root cause analysis to resolve design anomalies and incorporate design changes as necessary
• Work with external vendors to build prototypes and evaluate performance. Perform ECT testing together with the V&V team, guide the test team as an SME
Skills for Success:
• BSME with 8+ years of medical device, mechanical design engineering and product development experience with disposables such as catheters, blood clot removal devices, etc. required.
• SolidWorks and FEA. Mold flow analysis is an advantage
• GD & T, Detailed drawings, Tolerance analysis
• Ability to implement DFM and DFA principles into product design and conduct risk analysis
• Knowledge of standard laboratory test methods for mechanical functional parameters
• Ability to perform root cause analysis using both experimental and statistical analyses
• Knowledge of plastics and injection molding